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- 3D cell-based biosensors in drug discovery programs microtissue engineering for high throughput screening — Developing a national registry of pharmacologic and biologic clinical trials workshop report (2006) (100)
- Development of antibody-based therapeutics translational considerations — Introduction to pharmacology. 2nd ed. (100)
- Introduction to toxicology — Pharmacokinetics in drug development. Volume 3, Advances and applications (100)
- Pharmacokinetics in drug discovery and development — What your patients need to know about psychiatric medications (99)
- 1. Translational Strategies for Development of Antibody-Based Therapeutics: An Overview / Mohammad Tabrizi, Gadi Gazit Bornstein and Scott L. Klakamp -- 2. Discovery Process for Antibody-Based Therapeutics / Heather H. Shih -- 3. Technologies for the Generation of Human Antibodies / Ramesh R. Bhatt, John S. Haurum and C. Geoffrey Davis -- 4. Application of Antibody Engineering in the Development of Next Generation Antibody-Based Therapeutics / Randall J. Brezski and Juan Carlos Almagro -- 5. Biophysical Considerations for Development of Antibody-Based Therapeutics / Andrew W. Drake and Giuseppe A. Papalia -- 6. Considerations in Establishing Affinity Design Goals for Development of Antibody-Based Therapeutics / Mohammad Tabrizi -- 7. Bioanalytical Considerations for Development of Antibody-Based Therapeutics: Pharmacokinetics and Immunogenicity / Cherryl B. Funelas and Scott L. Klakamp -- 8. Preclinical Considerations for Development of Antibody-Based Therapeutics in Oncology / Gregory Landes and Kathleen Elias -- 9. Factors Impacting the Tumor Localization and Distribution of Antibody-Based Therapeutics in Oncology / David C. Blakey -- 10. Preclinical Safety Considerations for the Development of Antibody-Based Therapeutics / Lolke de Haan -- 11. Application of Pharmacokinetic/Pharmacodynamic Modeling in the Development of Antibody-Based Therapeutics / Donald E. Mager -- 12. Application of Population Pharmacokinetic-Pharmacodynamic Approaches in the Design of Translational Strategies for Development of Antibody-Based Therapeutics / Feng Jin -- 13. Translational Biomarkers: Essential Tools in Development of Antibody-Based Therapeutics / Mohammad A. Tabrizi and Cherryl B. Funelas -- 14. Translational Research in Alzheimer's Disease for Development of Antibody-Based Therapeutics / Eric C. Yuen, Enchi Liu and Gene G. Kinney -- 15. Considerations in Manufacturing Process Development for Antibody-Based Therapeutics / Paula C. Miller and Peiling Xu -- 16. Strategies for Development of Next Generation Antibody-Based Therapeutics / Mohammad Tabrizi and Gadi Gazit Bornstein -- 17. Immune Complex Therapies for Treatment of Immune Thrombocytopenia / Rong Deng and Joseph P. Balthasar -- 18. Application of Bioinformatics Principles for Target Evaluation / Anthony Carvalloza, Mohammad Fallahi and Sahba Tabrizifard -- 19. Concluding Remarks / Mohammad Tabrizi, Gadi Gazit Bornstein and Scott L. Klakamp.
- The development of innovative drugs is becoming more difficult while relying on empirical approaches. This inspired all major pharmaceutical companies to pursue alternative model-based paradigms. The key question is: How to find innovative compounds and, subsequently, appropriate dosage regimens?
- Development of novel vaccines gives an overview of the tasks in basic research leading to the final product â" the vaccine and its applications, belonging to the most complex biologics in the pharmaceutical field. Distinct from most textbooks in the vaccine arena, the current issue focuses on the translational aspect, namely, how research results can be transformed into life-saving medical interventions. Each chapter of the book deals with one important paradigm for the development of novel vaccines, along the value chain towards the final vaccine, and furthermore, with the inevitable tools required for this process. Contributions are prepared by teams of scientists, all of whom are experts in the field, most of them anchored in biomedical organizations devoted to translational culture, thereby lighting the certain topics from different views. This volume is a must read for researchers engaged in vaccine development and who really want to see their research results to become a product.
- Diabetes perspectives in drug therapy 2011SpringerTargeting type 2 diabetes -- Dual acting and pan-PPAR activators as potential anti-diabetic therapies -- GLP-1 agonists and dipeptidyl-peptidase IV inhibitors -- Cannabinoids and endocannabinoids in metabolic disorders with focus on diabetes -- SGLT inhibitors as new therapeutic tools in the treatment of diabetes -- Inhibitors of 11[beta]-hydroxysteroid dehydrogenase type 1 in antidiabetic therapy -- Nampt and its potential role in inflammation and type 2 diabetes -- Inhibition of ganglioside biosynthesis as a novel therapeutic approach in insulin resistance -- Overcoming insulin resistance with ciliary neurotrophic factor -- Thermogenesis and related metabolic targets in anti-diabetic therapy -- Interleukin-targeted therapy for metabolic syndrome and type 2 diabetes -- Fructose-1, 6-bisphosphatase inhibitors for reducing excessive endogenous glucose production in type 2 diabetes -- AMP-activated protein kinase and metabolic control -- Mitochondria as potential targets in antidiabetic therapy -- Research and development of glucokinase activators for diabetes therapy : theoretical and practical aspects.
- Discussion framework for clinical trial data sharing guiding principles, elements, and activities 2014NAP"Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities."--Publisher's website.
- DNA topoisomerases and cancer 2012SpringerIntroduction and historical perspective / Patrick Forterre -- Human DNA topoisomerase I : structure, enzymology and biology / James J. Champoux -- Mitochondrial topoisomerases / Ilaria Dalla Rosa, Yves Pommier, and Hongliang Zhang -- Structure and mechanism of eukaryotic type IIA topoisomerases / James M. Berger and Neil Osheroff -- Essential functions of topoisomerase III-alpha in the nucleus and mitochondria / Stefanie Hartman Chen, Jianhong Wu, and Tao-shih Hsieh -- DNA topoisomerase I and illegitimate recombination / Céline Auzanneau and Philippe Pourquier -- Topoisomerase-induced DNA damage / Yves Pommier and Neil Osheroff -- Topoisomerases and carcinogenesis : topoisomerases III-alpha and BLM / Mounira Amor-Guéret and Jean-François Riou -- Topoisomerases inhibitors : a paradigm for interfacial inhibition / Christophe Marchand and Yves Pommier -- Topoisomerases I inhibitors : chemical biology / Beverly A. Teicher -- Topoisomerases II inhibitors : chemical biology / Anna Rogojina ... [et al.] -- Topoisomerases I inhibitors : current use and prospects / Yan Makeyev ... [et al.] -- Topoisomerases II inhibitors : current use and prospects / Olivier Mir ... [et al.] -- Transcriptional stress by camptothecin : mechanisms and implications for the drug antitumor activity / Giovanni Capranico ... [et al.] -- Mechanisms regulating cellular responses to DNA topoisomerases I-targeted agents / Piero Benedetti and Mary-Ann Bjornsti -- Tyrosyl-DNA-phosphodiesterase / Thomas S. Dexheimer ... [et al.] -- Ubiquitin and ubiquitin-like proteins in repair of topoisomerases-mediated DNA damage / Shyamal D. Desai -- Repair of topoisomerases II-mediated DNA damage : fixing DNA damage arising from a protein covalently trapped on DNA / John L. Nitiss ... [et al.] -- Topoisomerases and apoptosis / Olivier Sordet and Stéphanie Solier.
- Dopamine 2005ScienceDirect
- Dopamine receptors. 2nd ed. 2010Springer
- Dose finding by the continual reassessment method 2011CRCnetBASEPart I. Fundamentals -- Chapter 1. Introduction -- Chapter 2. Dose Finding in Clinical Trials -- Chapter 3. The Continual Reassessment Method -- Chapter 4. One-Parameter Dose-Toxicity Models -- Chapter 5. Theoretical Properties -- Chapter 6. Empirical Properties -- Part II. Design Calibration -- Chapter 7. Specifications of a CRM Design -- Chapter 8. Initial Guesses of Toxicity Probabilities -- Chapter 9. Least Informative Normal Prior -- Chapter 10. Initial Design -- Part III. CRM and Beyond -- Chapter 11. The Time-to-Event CRM -- Chapter 12. CRM with Multiparameter Models -- Chapter 13. When the CRM Fails -- Chapter 14. Stochastic Approximation.
- Drug delivery 2010SpringerThis volume gives a topical overview of various modern approaches to drug targeting covering today's options for specific carrier systems allowing successful drug treatment at various sites of the body difficult to address and increasing the benefit-risk-ratio.
- Drug delivery systems 2008Springer ProtocolsDrug delivery systems--an overview / Kewal K. Jain -- The role of the adeno-associated virus capsid in gene transfer / Kim M. Van Vliet ... [et al.] -- Delivering small interfering RNA for novel therapeutics / Patrick Y. Lu and Martin C. Woodle -- Catheters for chronic administration of drugs into brain tissue / Michael Guarnieri, Benjamin S. Carson, Sr., and George I. Jallo -- Transdermal drug delivery systems : skin perturbation devices / Marc B. Brown ... [et al.] -- Controlling the release of proteins/peptides via the pulmonary route / Sunday A. Shoyele -- Engineering protein particles for pulmonary drug delivery / Sunday A. Shoyele -- 2B-Trans technology : targeted drug delivery across the blood-brain barrier / Pieter J. Gaillard and Albertus G. de Boer -- Drug delivery in cancer using liposomes / Crispin R. Dass -- pH-responsive nanoparticles for cancer drug deliery / Youqing Shen ... [et al.] -- Extended-release oral drug delivery technologies : monolithic matrix systems / Sandip B. Tiwari and Ali R. Rajabi-Siahboomi.
- Drug delivery systems advanced technologies potentially applicable in personalised treatment 2013SpringerPolymers in Drug Delivery: Concepts, Developments and Potential / Rongjun Chen -- Amphiphilic Molecules in Drug Delivery Systems / Salomé dos Santos, Bruno Medronho -- Sizing Nanoparticles in Liquids: An Overview of Methods / Margarida Figueiredo -- Nanoparticles for Oral Delivery of Insulin / Antonio J. Ribeiro, Raquel Seiça -- Bioartificial Pancreas: In the Road to Clinical Application / Joana Crisóstomo, Jorge F. J. Coelho -- Cationic Liposome-Based Systems for Nucleic Acid Delivery: From the Formulation Development to Therapeutic Applications / Henrique Faneca, Ana Luísa Cardoso -- Biomaterial-Based Vectors for Targeted Delivery of Nucleic Acids to the Nervous System / Ana Paula Pêgo, Hugo Oliveira -- Biofabrication of Hydrogel Constructs / Rúben F. Pereira, Henrique A. Almeida -- The Warburg Effect Is a Guide to Multipurpose Cancer Therapy Including Trace Element Delivery / Anatoliy V. Popov, Leonid G. Menchikov -- In Silico Research in Drug Delivery Systems / André Filipe Ferreira, Rodrigo José Lopes -- The Importance of Controlled/Living Radical Polymerization Techniques in the Design of Tailor Made Nanoparticles for Drug Delivery Systems / Nuno Rocha, Patrícia Mendonça, Joana R. Góis.
- Section A. Introduction -- section B. Clinical pharmacokinetics -- section C. Human studies in clinical pharmacology -- section D. Regulations.
- Drug discovery and evaluation. Pharmacological assays. 3rd completely rev., updated, and enl. ed. 2008Springer
- Section I, Safety pharmacology: -- Introduction to safety pharmacology -- Status of safety pharmacology and present guidelines -- Central nervous system (CNS) safety pharmacology studies -- Methods in cardiovascular safety pharmacology -- Safety pharmacology of drugs for the urinary tract -- Respiratory function assays in safety pharmacology -- Metabolism pharmacology -- Peripheral nervous system -- Safety of intravenous and inhalation anesthetics -- Side effects of central analgesic drugs -- Safety pharmacology of antiinflammatory drugs -- Safety pharmacology of drugs with osteoarthritis-related activity -- Safety pharmacology of blood constituents -- Ocular toxicity tests -- Assays in endocrine safety pharmacology -- Safety assays in skin pharmacology -- Magnetic resonance imaging in pharmaceutical safety assessment -- Section II, Safety pharmacokinetics: -- Introduction -- Physicochemical properties -- In-silico ADME modeling -- Absorption-in vitro tests-cell based -- Absorption-in vitro tests-non cell based -- Distribution-in vitro tests-protein binding -- Perfused organs -- Metabolism studies in vitro and in vivo -- Distribution-across barriers -- Drug-drug interaction-enzyme induction -- Drug-drug interaction-enzyme inhibition -- Absorption -- In vivo distribution -- Distribution-in vivo-other methods -- Bioanalytical assays-Toxicokinetics -- Bioanalytical assays-liquid chromatography coupled to tandem spectrometry -- Bioanalytical assays-gas chromatography -- Bioanalytical assays-RIA/EIA -- Clinical studies-typical designs -- Pharmacogenomics in DME -- Typical PK/PD approaches -- Population kinetics in drug development -- Section III, Safety toxicology: -- Introduction -- International guidelines for the development of pharmaceutical compounds -- General toxicity -- In silico methods -- Alternative methods for carcinogenicity testing -- Genotoxicity -- Reproductive toxicology -- Application of toxicoproteomics in profiling drug effects.
- Drug interactions in infectious diseases. 3rd ed. 2011SpringerIntroduction to Drug-Drug Interactions -- Mechanisms of Drug Interactions I: Absorption, Metabolism, and Excretion -- Mechanisms of Drug Interactions II: Transport Proteins -- Drug-Food Interactions -- Interactions Between Herbs and Antiinfective Medications -- Drug-Cytokine Interactions -- Beta-Lactam Antibiotics -- Macrolides, Azalides, and Ketolides -- Quinolones -- Glycopeptides, Lipopeptides, and Lipoglycopeptides -- Miscellaneous Antibiotics -- Drugs for Tuberculosis -- Drug Interactions with Antiretrovirals for HIV Infection -- Non-HIV Antiviral Agents -- Antifungal Agents -- Antimalarial Agents -- Antiprotozoal and Anthelmintic Agents -- Drug Interaction Considerations Throughout Drug Development -- Probe Cocktail Studies -- Design and Data Analysis in Drug Interaction Studies.
- Drug metabolism and pharmacokinetics quick guide 2011Springer1. Pharmacokinetics -- 2. Drug Metabolizing Enzymes -- 3. Oral Absorption -- 4. Transporters -- 5. Metabolism-Based Drug Interactions -- 6. Biotransformation and Bioactivation -- 7. Prediction of Human Pharmacokinetics -- 8. Advances in Bioanalysis as It Relates to ADME -- 9. ADME Properties and Their Dependence on Physicochemical Properties -- 10. In Silico ADME Tools -- 11. Approved Drugs -- 12. Chemical Nomenclature.
- Drug metabolism and transport molecular methods and mechanisms 2005Springer ProtocolsRenal cytochrome P450s and flavin-containing monooxygenases : potential roles in metabolism and toxicity of 1,3-butadiene, trichloroethylene, and tetrachloroethylene / Adnan A. Elfarra -- Experimental approaches for the study of cytochrome P450 gene regulation / Hollie I. Swanson ... [et al.] -- Insulin and growth factor signaling : effects on drug metabolizing enzymes / Sang K. Kim, Kimberly J. Woodcroft, and Raymond F. Novak -- Catalytic function and expression of glutathione transferase zeta / Philip G. Board, M.W. Anders, and Anneke C. Blackburn -- Glucuronidation of fatty acids and prostaglandins by human udp glucuronosyltransferases / Anna Radominska-Pandya, Joanne M. Little and Arthur Bull -- Transcriptional regulation of UDP-glucuronosyltransferases / Anna Radominska-Pandya, Peter I. Mackenzie, and Wen Xie -- Phenotypic and genotypic characterization of n-acetylation / Craig K. Svensson and David W. Hein -- Methods and approaches to study metabolism and toxicity of acetaminophen / Sam A. Bruschi -- Modulation of drug metabolism and antiviral therapies / Bernhard H. Lauterburg -- Modulation of thiols and other low-molecular-weight cofactors : effects on drug metabolism and disease susceptibility / Charles V. Smith -- Multidrug resistance proteins and hepatic transport of endo- and xenobiotics / Phillip M. Gerk and Mary Vore -- Structural determinants of folate and antifolate membrane transport by the reduced folate carrier / Wei Cao and Larry H. Matherly -- Glutathione transport in the kidneys : experimental models, mechanisms, and methods / Lawrence H. Lash -- Human cytosolic sulfotransferases : properties, physiological functions, and toxicology / Charles N. Falany.
- Drug metabolism current concepts 2005Springer
- Drug product development for the back of the eye 2011SpringerThis comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs. Specific topics covered in this book include: Solution, suspension, gel, nanoparticle, microparticle, and implant dosage forms; Refillable and microneedle devices; Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery; Physical methods including iontophoresis for drug delivery; Rational selection of routes of administration and delivery systems; Noninvasive and continuous drug monitoring; Clinical endpoints and regulatory path to drug product development; Emerging and existing drugs and drug targets.
- Drug resistance in cancer cells 2009SpringerMultidrug Resistance Mediated by MDR-ABC Transporters / Gergely Szakács ... [et al.] -- Metastasis and Drug Resistance / Dominic Fan ... [et al.] -- The Role of Autophagy and Apoptosis in the Drug Resistance of Cancer / Tomohisa Yokoyama ... [et al.] -- Mechanisms of Resistance to targeted Tyrosine Kinase Inhibitors / Stacey J.Baker, E. Premkumar Reddy -- Targeting Transglutaminase-2 to overcome Chemoresistance in Cancer Cells / Kapil Mehta, Jansina Y. Fok -- Extracellular Matrix-Mediated Drug Resistance / P.S. Hodkinson, Tariq Sethi -- Oxidative Stress and Drug Resistance in Cancer / Dunyaporn Trachootham, Wan Zhang, Peng Huang -- Nuclear Factor-kB and Chemoresistance / Ajaikumar B.Kunnumakkara, Preetha Anand, Bharat B. Aggarwal -- Drug Resistance and the Tumor Suppressor p53 : The Paradox of Wild-Type Genotype in Chemorefractory Cancers / Zahid H. Siddik -- Resistance to Differentiation Therapy / Bulent Ozpolat -- MicroRNAs and Drug Resistance / Elisa Barbarotto, George A. Calin -- Molecular Signatures of Drug Resistance / Melissa A. Troester, Jason I. Herschkowitz, Katherine A. Hoadley -- Assessment of Drug Resistance in Anticancer Therapy by Nuclear Imaging / Natalie Charnley, Catharine West, Pat Price -- Overcoming Drug Resistance by Phytochemicals / Marion M. Chan, Dunne Fong.
- Drug resistance in leishmania parasites consequences, molecular mechanisms and possible treatments 2013Springer
- Drug safety evaluation methods and protocols 2009Springer ProtocolsDeveloping Combination Drugs in Preclinical Studies / Alberto Lodola -- Preclinical Evaluation of Juvenile Toxicity / Paul C. Barrow, Stéphane Barbellion, Jeanne Stadler -- Necropsy and Sampling Procedures in Rodents / Laurence Fiette, Mohamed Slaoui -- Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation / Mohamed Slaoui, Laurence Fiette -- Principles and Methods of Immunohistochemistry / José A. Ramos-Vara -- Tissue Microarrays and Digital Image Analysis / Denise Ryan, Laoighse Mulrane, Elton Rexhepaj, William M. Gallagher -- Micronucleus Assay and Labeling of Centromeres with FISH Technique / Ilse Decordier, Raluca Mateuca, Micheline Kirsch-Volders -- The Use of Bacterial Repair Endonucleases in the Comet Assay / Andrew R. Collins -- Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel / Xiao-Liang Chen, Jiesheng Kang, David Rampe -- Generation and Analysis of Transcriptomics Data / Philip D. Glaves, Jonathan D. Tugwood -- Protocols of Two-Dimensional Difference Gel Electrophoresis to Investigate Mechanisms of Toxicity / Emmanuelle Com, Albrecht Gruhler, Martine Courcol, Jean-Charles Gautier -- Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR / Gabriel Baverel, Sophie Renault, Hassan Faiz, Maha Hage, Catherine Gauthier, Agnès Duplany, Bernard Ferrier, Guy Martin -- Statistical Analysis of Quantitative RT-PCR Results / Richard Khan-Malek, Ying Wang -- Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes / Jean-Pierre Marchandeau, Gilles Labbe -- FETAX Assay for Evaluation of Developmental Toxicity / Isabelle Mouche, Laure Malesic, Olivier Gillardeaux -- Evaluation of Embryotoxicity Using the Zebrafish Model / Lisa Truong, Stacey L. Harper, Robert L. Tanguay -- Protocols of In Vitro Protein Covalent Binding Studies in Liver / Jean-François Lévesque, Stephen H. Day, Allen N. Jones -- Utilization of MALDI-TOF to Determine Chemical-Protein Adduct Formation In Vitro / Ashley A. Fisher, Matthew T. Labenski, Terrence J. Monks, Serrine S. Lau -- Utilization of LC-MS/MS Analyses to Identify Site-Specific Chemical Protein Adducts In Vitro / Ashley A. Fisher, Matthew T. Labenski, Terrence J. Monks, Serrine S. Lau / One-Dimensional Western Blotting Coupled to LC-MS/MS Analysis to Identify Chemical-Adducted Proteins in Rat Urine / Matthew T. Labenski, Ashley A. Fisher, Terrence J. Monks, Serrine S. Lau -- Identification of Chemical-Adducted Proteins in Urine by Multi-dimensional Protein Identification Technology (LC/LC-MS/MS) / Matthew T. Labenski, Ashley A. Fisher, Terrence J. Monks, Serrine S. Lau -- Optimization of SELDI for Biomarker Detection in Plasma / Jean-Francois Léonard, Martine Courcol, Jean-Charles Gautier -- Differential Proteomics Incorporating iTRAQ Labeling and Multi-dimensional Separations / Ben C. Collins, Thomas Y. Lau, Stephen R. Pennington, William M. Gallagher -- NMR and MS Methods for Metabonomics / Frank Dieterle, Björn Riefke, Götz Schlotterbeck, Alfred Ross, Hans Senn, Alexander Amberg -- Absolute Quantification of Toxicological Biomarkers by Multiple Reaction Monitoring / Thomas Y. Lau, Ben C. Collins, Peter Stone, Ning Tang, William M. Gallagher, Stephen R. Pennington.
- Drug transporters 2011SpringerUptake transporters of the human OATP family / Jörg König -- In vitro and in vivo evidence of the importance of organic anion -- transporters (OATs) in drug therapy / Gerhard Burckhardt and Birgitta Christina Burckhardt -- Organic cation transporters (OCTs, MATEs), in vitro and in vivo evidence for the importance in drug therapy / Anne T. Nies et al. -- Role of the intestinal bile acid transporters in bile acid and drug disposition / Paul A. Dawson -- The role of the sodium-taurocholate cotransporting polypeptide (NTCP) and of the bile salt export pump (BSEP) in physiology and pathophysiology of bile formation / Bruno Stieger -- P-glycoprotein: tissue distribution, substrates, and functional consequences of genetic variations / Ingolf Cascorbi -- Importance of P-glycoprotein for drug-drug interactions / Hartmut Gläser -- Multidrug resistance proteins (MRPs, ABCCs): importance for pathophysiology and drug therapy / Dietrich Keppler -- In vitro and in vivo evidence for the importance of breast cancer resistance protein transporters(BCRP/MXR/ABCP/ABCG2) / Henriette E. Meyer zu Schwabedissen and Heyo K. Kroemer -- Molecular mechanisms of drug transporter regulation / Rommel G. Tirona -- In vivo probes of drug transport: commonly used probe drugs -- to assess function of intestinal P-glycoprotein (ABCB1) in humans / Stefan Oswald, Bernd Terhaag, and Werner Siegmund.
- Print MaterialThis book provides vital information about drug-DNA interactions. Understand the types of structural and bonding information that can be obtained using specific physico-chemical methods and discover how to design new drugs that are more effective than current treatments and have fewer side effects. Find detailed information about X-ray crystallography, NMR spectroscopy, molecular modeling, and optical spectroscopy such as UV-Visible absorption, fluorescence, circular dichroism (CD), flow linear dichroism (FLD), infrared (IR) and Raman spectroscopy.
- Drug-induced liver disease. 3rd ed. 2013ScienceDirectI. Mechanisms of liver injury. Drug-induced liver injury / Neil Kaplowitz -- Cytochrome P450 activation of toxins and hepatotoxicity / F. Peter Guengerich -- Mechanistic role of acyl glucuronides / Howard Horng, Hilde Spahn-Langguth, and Leslie Z. Benet -- Oxidant stress, antioxidant defense, and liver injury / Mitchell R. McGill and Hartmut Jaeschke -- Hepatotoxicity due to mitochondrial injury / John J. Lemasters -- Mechanisms of cell death and relevance to drug toxicity / Lily Dara, Derick Han, and Neil Kaplowitz -- Role of membrane transport in hepatotoxicity and pathogenesis of drug-induced cholestasis / Bruno Stieger and Gerd A. Kullak-Ublick -- Liver sinusoidal endothelial cells and liver injury / Laurie D. Deleve -- Macrophages and kupffer cells in drug-induced liver injury / Mark Barnes ... [et al.] -- Role of inflammation in drug-induced liver injury / Robert A. Roth and Patricia E. Ganey -- Role of the adaptive immmune system in idiosyncratic drug-induced liver injury / Jack Uetrecht -- Role of tissue repair and death proteins in liver injury / Harihara M. Mehendale -- Genetic factors in the pathogenesis of drug-induced liver injury / Ann K. Daly and Christopher P. Day -- II. Diagnosis and management. Clinical manifestations and management of drug-induced liver diseases / Willis C. Maddrey -- Histopathological evaluationof drug-induced liver disease / David E. Kleiner -- Risk factors for drug-induced liver disease / Raj Vuppalanchi and Maga Chalasani -- Biomarkers for drug-induced liver injury / Paul B. Watkins -- Causality assessment / M. Isabel Lucena ... [et al.] -- III. Hepatotoxicity of specifid drugs. Mechanisms of acetaminophen-induced liver disease / Jack A. Hinson -- Acetaminophen / Laura P. James -- Mechanisms underlying the hepatotoxicity of nonsteroidal antiinflammatory drugs / Urs A. Boelsterli -- Nonsteroidal antiinflammatory drugs and leukotriene receptor antagonists / James H. Kewis and Jonathan G. Stine -- Mechanism, pathology, and clinical presentation of hepatotoxicity of anesthetic agents / J. Gerald Kenna -- Anticonvulsant agents / Munir Pirmohamed and J. Steven Leeder -- Hepatotoxicity of psychotropic drugs and drugs of abuse / Dominique Larrey and Marie-Pierre Ripault -- Hepatotoxicity of antimicrobials and antifungal agents / Richard H. Moseley -- Hepatotoxicity of antitubercular drugs / Sumita Verma and Neil Kaplowitz -- Hepatotoxicity of antiviral agents / Marina Núñez -- Hepatotoxicity of cardiovascular and antidiabetic drugs / Dina Halegoua-De Marzio and Victor J. Navarro -- Cancer chemotherpay / Laurie D. Deleve -- Hepatotoxicity of immunosuppressive drugs / Adrian Reuben -- Hepatotoxicity related to methotrexate / Guruprasad P. Aithal -- Adverse effects of hormones and hormone antagonists on the liver / Shivakumar Chitturi and Geoffrey C. Farrell -- Mushroom poisoning / François Durand and Dominique Valla -- Hepatotoxicity of herbals and dietary supplements / Leonard Seeff, Felix Stickel, and Victor J. Navarro -- Occupational and environmental hepatotoxicity / Keith G. Tolman and Anthony S. Dalpiaz -- Chronic liver disease from drugs / Einar S. Björnsson -- IV. Future directions. Regulatory perspectives / Mark I. Avigan -- Drug-induced liver injury research networks / Robert J. Fontana -- LiverTox / Jay H. Hoofnagle.
- Drug-related problems in the elderly 2009Springer
- Drugs affecting 5-HT systems the transcript of a witness seminar held by the History of Modern Biomedicine Research Group, Queen Mary, University of London, on 20 November 2012 2013Wellcome Trust
- Drugs compromising male sexual health 2008SpringerMale sexual health -- Structure and physiology of the testis -- Introduction -- The spermatozoa -- Sperm motility -- Capacitation and acrosome reaction -- Fertilization of the oocyte -- Testing substances that compromise spermatogenesis and fertility (adapted from Creasy 1997) -- Testosterone production and testosterone effects -- Physiology of erection -- Introduction -- Role of androgens in erection -- Priapism -- Physiology of ejaculation -- Drugs which compromise male sexual health -- Adverse drug effects -- Male sexual health and drugs -- Drugs which compromise testicular function -- Drugs which compromise erectile function -- Drugs which compromise ejaculation -- Database of drugs.
- Drugs for HER2-positive breast cancer 2011Springer"Growth factor receptors have long been known to drive malignant transformation and cancer progression. The epidermal growth factor receptor (EGFR, ErbB, HER) system is likely the best described membrane receptor tyrosine kinase family in malignant tumors. With implementation of the growth-inhibitory anti-HER-2 antibody trastuzumab (Herceptin) for the treatment of HER-2-positive advanced metastatic breast cancer, a new era has dawned in the therapy of this malignant disease. Unfortunately, trastuzumab-sensitive cancers invariably develop resistance to the antibody after some time. Recent clinical studies have revealed that these refractory tumors are still responsive to inhibition of the HER receptor family using dual HER-1/-2 inhibitors such as lapatinib (Tykerb/Tyverb). Moreover, a multiplicity of novel, improved irreversibly acting small molecular HER tyrosine kinase inhibitors are in the pipeline of many drug developing companies and are being evaluated in the clinical setting."
- Elsevier's Integrated review pharmacology. 2nd ed. 2007ClinicalKeyPharmakokinetics -- Pharmacodynamics and signal transduction -- Toxicology -- Treatment of infectious diseases -- Cancer and immunopharmacology -- Autonomic nervous system -- Hematology -- Cardiovascular system -- Renal system -- Inflammatory disorders -- Gastrointestinal pharmacology -- Endocrine pharmacology -- Central nervous system.
- 1. Introduction -- 2. Investigative Toxicology: The State of the Art -- 3. Screening Technologies I: Human Cell-Based Approaches -- 4. Screening Technologies II: Toxicogenomics -- 5. Screening Technologies III: Metabolomics -- 6. Screening Technologies IV: Pharmacogenetics -- 7. Qualifying Biomarkers -- 8. Pharmacovigilance -- 9. Integration -- 10. The Future of Safety Science.
- Part 1. Overview of Non-Cannabinoid Receptors -- Overview of Nonclassical Cannabinoid Receptors / Grzegorz Godlewski and George Kunos -- Overview of Non-CB1/CB2 Cannabinoid Receptors: Chemistry and Modeling / Evangelia Kotsikorou and Patricia Reggio -- Part 2. G-Protein Coupled Receptors -- GPR55 in the CNS / Hui-Chen Lu, Jane E. Lauckner, John W. Huffman and Ken Mackie -- The Role of GPR55 in Bone Biology / Lauren S. Whyte and Ruth A. Ross -- The Role of GPR55 in Cancer / Clara Andradas, María M. Caffarel, Eduardo Pérez-Gómez, Manuel Guzmán and Cristina Sánchez -- GPR18 and NAGly Signaling: New Members of the Endocannabinoid Family or Distant Cousins? / Douglas McHugh and Heather B. Bradshaw -- Cannabinoid Signaling Through Non-CB1R/Non-CB2R Targets in Microglia / Neta Rimmerman, Ewa Kozela, Rivka Levy, Zvi Vogel and Ana Juknat -- Part 3. Ion Channels -- Temperature-Sensitive Transient Receptor Potential Channels as Ionotropic Cannabinoid Receptors / Vincenzo Di Marzo and Luciano De Petrocellis -- Nonpsychoactive Cannabinoid Action on 5-HT3 and Glycine Receptors / Li Zhang and Wei Xiong -- Part 4. Transcription Factors -- Peroxisome Proliferator-Activated Receptors and Inflammation / James Burston and David Kendall -- Peroxisome Proliferator-Activated Nuclear Receptors and Drug Addiction / Paola Mascia, Gianluigi Tanda, Sevil Yasar, Stephen J. Heishman and Steven R. Goldberg -- Part 5. Conclusions/Therapeutic Potential -- Conclusions: Therapeutic Potential of Novel Cannabinoid Receptors / Mary E. Abood, Roger G. Sorensen and Nephi Stella.
- Epigenetics and disease pharmaceutical opportunities 2011SpringerDNA Methylation and Cancer -- Genome-Wide Epigenetic Modifications in Cancer -- DNA Repair and the Control of DNA Methylation -- Errors in Erasure: Links Between Histone Lysine Methylation Removal and Disease -- Histone Modifications in Cancer Biology and Prognosis -- Dynamics of Histone Lysine Methylation: Structures of Methyl Writers and Erasers -- Epigenetic Mechanisms of Mental Retardation -- Histone and DNA Modifications in Mental Retardation -- HDAC Inhibitors and Cancer Therapy -- Epigenetic Mechanisms in Acute Myeloid Leukemia -- The Liver-Specific MicroRNA miR-122: Biology and Therapeutic Potential -- Transcriptional Regulatory Networks in Embryonic Stem Cells -- Small Molecules in Cellular Reprogramming and Differentiation -- Index.
- Anti-Inflammatory Plants -- Plants Affecting the Central Nervous System -- Plants for Chemotherapy of Neoplastic Diseases.
- Evaluation of enzyme inhibitors in drug discovery a guide for medicinal chemists and pharmacologists. 2nd ed. 2013Wiley"There has been explosive growth in the hunt for new pharmaceutically agents globally. Traditionally, this has been the purview of the pharmaceutical industry, but today, this effort crosses academic, government, and industry laboratories across the world. Enzymes remain the most valued and common of drug targets; hence, a detailed understanding of their interactions with inhibitors is critical to successful drug discovery. This book provides a practical, readable, and comprehensive treatment of these topics that allows scientists to master the art of applied enzymology for drug discovery. The book addresses the opportunities for inhibitor interactions with enzyme targets arising from consideration of the catalytic reaction mechanism; discusses how inhibitors are properly evaluated for potency, selectivity, and mode of action, covers the potential advantages and liabilities of specific inhibition modalities with respect to efficacy in vivo, and provides valuable biochemical insights to help medicinal chemists and pharmacologists most effectively pursue lead optimization. It includes two new chapters, one on the pioneering idea of drug-target residence time fostered by Dr. Copeland, and the second on quantitative biochemistry. Five new appendices are added"--Provided by publisher.
- Evaluation of enzyme inhibitors in drug discovery a guide for medicinal chemists and pharmacologists. [1st ed.]Print Material"This publication provides readers with a thorough understanding of enzyme-inhibitor evaluation to assist them in their efforts to discover and optimize novel drug therapies. Key topics such as competitive, noncompetitive, and uncompetitive inhibition, slow binding, tight binding, and the use of Hill coefficients to study reaction stoichiometry are all presented. Examples of key concepts are presented with an emphasis on clinical relevance and practical applications."--Jacket.
- This volume presents recent developments in the novel drug development and potential of extremophilic cyanobacteria. It discusses how these tiny organism originated, produce oxygen that leads to evolution of life on the earth, how their survival strategies in extreme climatic conditions lead to diverse metabolic pathways, and the opportunity to use them to develop novel drugs. The book is comprised of five chapters, starting with the origin of cyanobacteria, their survival strategies under extreme conditions, and their capabilities to change metabolic activities.The second chapter explores the different metabolic pathways found in cyanobacteria and examines advances in this field and recent techniques like MALDI-TOF imaging and metagenomics tools as well as in silico techniques for rapid screening of secondary metabolites. Further chapters cover the glycomics of cyanobacteria, anticancer drug development, and some issues and challenges of using cyanobacteria to develop drugs. Extremophilic Cyanobacteria For Novel Drug Development provides insight into future perspectives in drug development and is a key resource for students, researchers and professionals in pharmacy, medicinal chemistry, pharmacognosy biotechnology, biology, and academics.
- FDA administrative enforcement manual 2005CRCnetBASE
- FDA bioequivalence standards 2014SpringerThis comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
- Federal agency roles in cancer drug development from preclinical research to new drug approval the National Cancer Institute and the Food and Drug Administration: background paper prepared for the National Cancer Policy Board 2005NAP
- Fertility control 2010SpringerPart 1. Female Reproduction -- New Insights into Ovarian Function / JoAnne S. Richards and Stephanie A. Pangas -- Estrogen Signaling in the Regulation of Female Reproductive Functions / J. K. Findlay, S. H. Liew, E. R. Simpson and K. S. Korach -- Progesterone Receptors and Ovulation / Orla M. Conneely -- Contraception Targets in Mammalian Ovarian Development / Eileen A. McLaughlin and Alexander P. Sobinoff -- Proteomics of Embryonic Implantation / T. Garrido-Gómez, F. Dominguez and C. Simón -- Evaluation of Plasma Membrane Calcium/Calmodulin-Dependent ATPase Isoform 4 as a Potential Target for Fertility Contro / Elizabeth J. Cartwright and Ludwig Neyses -- Part 2. Male Reproduction -- New Insights into Sperm Physiology and Pathology / R. John Aitken, Mark A. Baker, Geoffry N. De Iuliis and Brett Nixon -- The Epididymis as a Target for Male Contraceptive Development / B. T. Hinton and T. G. Cooper -- Sperm-Zona Pellucida Interaction: Molecular Mechanisms and the Potential for Contraceptive Intervention / Matthew D. Dun, Lisa A. Mitchell, R. John Aitken and Brett Nixon -- Mouse Models as Tools in Fertility Research and Male-Based Contraceptive Development / Duangporn Jamsai and Moira K. O'Bryan -- Part 3. New options: From target to product -- Male Hormonal Contraception / E. Nieschlag -- Family Planning: Today and in the Future / Michael J. K. Harper.
- Fighting multidrug resistance with herbal extracts, essential oils and their components 2013ScienceDirectFighting Multidrug Resistance with Herbal Extracts, Essential Oils and their Components offers scientists a single source aimed at fighting specific multidrug-resistant (MDR) microorganisms such as bacteria, protozoans, viruses and fungi using natural products. This essential reference discusses herbal extracts and essential oils used or under investigation to treat MDR infections, as well as those containing antimicrobial activity that could be of potential interest in future studies against MDR microorganisms. The need to combat multidrug-resistant microorganisms is an urgent one and this book provides important coverage of mechanism of action, the advantages and disadvantages of using herbal extracts, essential oils and their components and more to aid researchers in effective antimicrobial drug discovery . Addresses the need to develop safe and effective approaches to coping with resistance to all classes of antimicrobial drugs . Provides readers with current evidence-based content aimed at using herbal extracts and essential oils in antimicrobial drug development . Includes chapters devoted to the activity of herbal products against herpes, AIDS, tuberculosis, drug-resistant cancer cells and more.
- Food-drug synergy and safety 2006CRCnetBASE
- Fragment-based drug design tools, practical approaches, and examples 2011ScienceDirectThere are numerous excellent reviews on Fragment Based Drug Discovery (FBDD), but there are to date no hand-holding guides or protocols with which one can embark on this orthogonal approach to complement traditional high throughput screening methodologies. This Methods in Enzymology volume offers the tools, practical approaches, and hit-to-lead examples on how to conduct FBDD screens. The chapters in this volume cover methods that have proven to be successful in generating leads from fragments, including chapters on how to apply computational techniques, nuclear magnetic resonance, surface plasma resonance, thermal shift and binding assays, protein crystallography, and medicinal chemistry in FBDD. Also elaborated by experienced researchers in FBDD are sample preparations of fragments, proteins, and GPCR as well as examples of how to generate leads from hits. Offers the tools, practical approaches, and hit-to-lead examples on how to conduct FBDD screens. The chapters in this volume cover methods that have proven to be successful in generating leads from fragments, including chapters on how to apply computational techniques, nuclear magnetic resonance, surface plasma resonance, thermal shift and binding assays, protein crystallography, and medicinal chemistry in FBDD.
- Over the past decade, significant progress has been made in the theory and applications of pharmacodynamics of antimicrobial agents. On the basis of pharmacokinetic-pharmacodynamic modeling concepts it has become possible to describe and predict the time course of antimicrobial effects under normal and pathophysiological conditions. The study of pharmacokinetic-pharmacodynamic relationships can be of considerable value in understanding drug action, defining optimal dosing regimens, and in making predictions under new or changing pre-clinical and clinical circumstances. Not surprisingly, pharmacokinetic-pharmacodynamic modeling concepts are increasingly applied in both basic and clinical research as well as in drug development. Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics is designed as a reference on the application of pharmacokinetic-pharmacodynamic principles for the optimization of antimicrobial therapy, namely pharmacotherapy, and infectious diseases. The reader is introduced to various aspects of the fundamentals of antimicrobial pharmacodynamics, the integration of pharmacokinetics with pharmacodynamics for all major classes of antibiotics, from basic research to clinical situations.
- Fundamentals of pharmaceutical nanoscience 2013SpringerNanoscience and nanotechnology overview -- Liposome preparation and characterization -- Solid polymeric nanoparticles -- Lipid nanoparticles -- Polymeric vesicles -- Low molecular weight amphiphile micelles -- Polymeric micelles -- Niosomes -- Quantum dots -- Magnetic particles -- Drug nanoparticles -- Polymeric pro-drugs -- Therapeutic Applications of pharmaceutical nanosystems -- Drug solubilisation -- Gene therapy -- Chemotherapy -- Tissue engineering -- Anti-infectives -- Vaccination -- Anti-arthritic drugs -- Imaging agents -- Commercial exploitation of pharmaceutical nanosystems -- Future perspectives -- Multiple Choice -- Problem Sets -- Case Studies -- Suggested Reading.
- GABA receptors. 3rd ed. 2007Springer
- "This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher.
- Print MaterialGeneric drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter. How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. Questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Greene chronicles the social, political, and cultural history of generic drugs, narrating the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene's history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
- Genomic biomarkers for pharmaceutical development advancing personalized health care 2014ScienceDirectGenomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters written by international authorities in industry and academia, this work is a truly unique presentation of the thoughts and approaches that lead to the development of personalized medicine. Intended for all those involved in clinical translational research, this book is the ideal resource for scientists searching for the applications, strategies and successful approaches of translational science in pharmaceutical development. Provides case studies in applications of pharmacodynamic and predictive markers in drug development in oncology, autoimmunity, respiratory diseases and infectious diseases. Shows how to identify potential new therapeutic targets in different diseases and provides examples of potential new disease indications for life cycle management of drugs. Authored by leading international experts from industry and academia.
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA). In Europe, the members are the EU (Representatives of the European Commission and the European Medicines Agency [EMA]), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the United States, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) is the secretariat of the ICH. Additional members include Observers from WHO, European Free Trade Association (EFTA), and Canada. The Observers represent non-ICH countries and regions. This volume considers one of ICH's major categories, Safety, covering topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but in most cases there is a lack of awareness of the many issues that were addressed during the development of the consensus guidances. Further, just as it is important to understand what the guidances state, it is also important to understand the thoughts, debates, and intent of the experts involved, which are not included in the guidance documents. Why has the guideline been written as it is written, why are some topics ignored, and why have some initial guidance proposals have been deleted. These and other related questions and answers are the contents of this book, written by experts who were directly involved in writing the ICH guidances that drive drug development today.
- Introduction / Terrence P. Tougas, Jolyon P. Mitchell -- Current Approaches to APSD Measurements of OIPs Based on Inertial Impaction / Jolyon P. Mitchell, Daryl L. Roberts -- Physical Causes of APSD Changes in Aerosols from OIPs and Their Impact on CI Measurements / Helen Strickland, Beth Morgan -- Good Cascade Impactor Practices / Jolyon P. Mitchell -- The AIM and EDA Concepts: Why They Are Needed and How They Fit Together / Jolyon P. Mitchell, Terrence P. Tougas -- Product Life Cycle Approach to Cascade Impaction Measurements / Richard Bauer, J. David Christopher -- Theoretical Basis for the EDA Concept / Terrence P. Tougas, Jolyon P. Mitchell -- Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release / J. David Christopher, Helen Strickland -- Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data / Helen Strickland, Beth Morgan -- Validating AIM-Based Instrumentation and Associated Measurement Techniques / Mark Copley, Jolyon P. Mitchell -- The Regulatory and Compendial Pathways to Acceptance for AIM and EDA Concepts / Steven C. Nichols, Jolyon P. Mitchell -- Applying the AIM Concept in Support of Developing Improved In Vitro-In Vivo Relationships for OIPs / Jolyon P. Mitchell, Mark Copley -- Future Directions for the AIM and EDA Concepts / Terrence P. Tougas, Jolyon P. Mitchell -- Conclusions / Terrence P. Tougas, Svetlana A. Lyapustina.
- Print Material
- Goodman & Gilman's The Pharmacological basis of therapeutics. 12th ed. 2011 (12th ed.)AccessMedicineDrug invention and the pharmaceutical industry -- Pharmacokinetics: the dynamics of drug absorption, distribution, metabolism, and elimination -- Pharmacodynamics: molecular mechanisms of drug action -- Drug toxicity and poisoning -- Membrane transporters and drug response -- Drug metabolism -- Pharmacogenetics -- Neurotransmission: the autonomic and somatic motor nervous systems -- Muscarinic receptor agonists and antagonists -- Anticholinesterase agents -- Agents acting at the neuromuscular junction and autonomic ganglia -- Adrenergic agonists and antagonists -- 5-Hydroxytryptamine (serotonin) and dopamine -- Neurotransmission and the central nervous system -- Drug therapy of depression and anxiety disorders -- Pharmacotherapy of psychosis and mania -- Hyponotics and sedatives -- -- Opioids, analgesia, and pain management -- General anesthetics and therapeutic gases -- Local anesthetics -- Pharmacotherapy of the epilepsies -- Treatment of central nervous system degenerative disorders -- Ethanol and methanol -- Drug addiction -- Regulation of renal function and vascular volume -- Renin and angiotensin -- Treatment of myocardial ischemia and hypertension -- Pharmacotherapy of congestive heart failure -- Anti-arrhythmic drugs -- Blood coagulation and anticoagulant, fibrinolytic, and antiplatelet drugs -- Drug therapy for hypercholesterolemia and dyslipidemia -- Histamine, bradykinin, and their antagonists -- Lipid-derived autacoids: eicosanoids and platelet-activating factor -- Anti-inflammatory, antipyretic, and analgesic agents; pharmacotherapy of gout -- Immunosuppressants, tolerogens, and immunostimulants -- Pulmonary pharmacology -- Hematopoietic agents: growth factors, minerals, and vitamins -- Introduction to endocrinology: the hypothalamic-pituitary axis -- Thyroid and anti-thyroid drugs -- Estrogens and progestins -- Androgens -- ACTH, adrenal steroids, and pharmacology of the adrenal cortex -- Endocrine pancreas and pharmacotherapy of diabetes mellitus and hypoglycemia -- Agents affecting mineral ion homeostasis and bone turnover -- Pharmacotherapy of gastric acidity, peptic ulcers, and gastroesophageal reflux disease -- Treatment of disorders of bowel motility and water flux; anti-emetics; agents used in biliary and pancreatic disease -- Pharmacotherapy of inflammatory bowel disease -- General principles of antimicrobial therapy -- Chemotherapy of malaria -- Chemotherapy of protozoal infections: amebiasis, giardiasis, trichomoniasis, trypanosomiasis, leishmaniasis, and other protozoal infections -- Chemotherapy of helminth infections -- Sulfonamides, trimethoprim-sulfamethoxazole, quinolones, and agents for urinary tract infections -- Penicillins, cephalosporins, and other β-lactam antibiotics -- Aminoglycosides -- Protein synthesis inhibitors and miscellaneous antibacterial agents -- Chemotherapy of tuberculosis, mycobacterium avium complex disease, and leprosy -- Antifungal agents -- Antiviral agents (nonretroviral) -- Antiretroviral agents and treatment of HIV infection -- General principles of cancer chemotherapy -- Cytotoxic agents -- Targeted therapies: tyrosine kinase inhibitors, monoclonal antibodies, and cytokines -- Natural products in cancer chemotherapy: hormones and related agents -- Ocular pharmacology -- Dermatological pharmacology -- Contraception and pharmacotherapy of obstetrical and gynecological disorders -- Environmental toxicology; carcinogens and heavy metals -- Appendix I: Principles of prescription order writing and patient compliance -- Appendix II: Design and optimization of dosage regimens: pharmacokinetic data.
- ER-bound steps in the biosynthesis of G protein-coupled receptors / Christian Nanoff and Michael Freissmuth -- Role of chaperones in G Protein coupled receptor signaling complex assembly / Denis J. Dupré, Maha M. Hammad, Patrick Holland and Jaime Wertman -- GPCR oligomerization: contribution to receptor biogenesis / Kathleen Van Craenenbroeck -- The functional size of GPCRs: monomers, dimers or tetramers? / Darlaine Pétrin and Terence E. Hébert -- Regulation of post-Golgi traffic of G protein-coupled receptors / Guangyu Wu -- Regulated GPCR trafficking to the plasma membrane: general issues and the CCR5 chemokine receptor example / Hamasseh Shirvani, Gabriel Gätà and Stefano Marullo -- Regulatory processes governing the cell surface expression of LH and FSH receptors / Deborah L. Segaloff -- Chaperone-mediated assembly of G protein complexes / Barry M. Willardson and Christopher M. Tracy -- Synthesis and assembly of G protein [beta][gamma] dimers: comparison of in vitro and in vivo studies / Jane Dingus and John D. Hildebrandt -- Preferential assembly of G-[alpha][beta][gamma] complexes directed by the [gamma] subunits / Janet D. Robishaw -- G Protein trafficking / Philip B. Wedegaertner -- Differential assembly of GPCR signaling complexes determines signaling specificity / Pascal Maurice, Abla Benleulmi-Chaachoua and Ralf Jockers -- GPCR and voltage-gated calcium channels (VGCC) signaling complexes / Christophe Altier -- Pharmacological chaperones correct misfolded GPCRs and rescue function: protein trafficking as a therapeutic target / Guadalupe Maya-Núñez, Alfredo Ulloa-Aguirre, Jo Ann Janovick and P. Michael Conn.
- Introduction to therapeutic drug monitoring. -- Monitoring free drug concentration. -- Analytical techniques for measuring concentrations of therapeutic drugs in biological fluids. -- The pre-analytical phase of drug testing: from specimen collection to analysis. -- Effect of hemolysis, high bilirubin, lipemia, paraproteins, and system factors on therapeutic drug monitoring. -- Digoxin: so many interferences and how to eliminate them. -- Interferences with measurement of anticonvulsants. -- Pitfalls in measuring antidepressant drugs. -- Immunosuppressive drugs: pharmacokinetics, preanalytic variables, and analytical considerations. -- Therapeutic drug monitoring in human immunodeficiency virus/acquired immunodeficiency syndrome. -- Pharmacogenetics and personalized medicine: issues and methodology. -- Interference of heterophilic and other antibodies in measurement of therapeutic drugs by immunoassays. -- Drug-herb and drug-food interactions: impact on therapeutic drug monitoring. -- Toxic element testing with clinical specimens. -- Alcohol testing. -- Introduction to drugs of abuse testing. -- Urinary adulterants and drugs of abuse testing. -- Hair, oral fluid, sweat, and meconium testing for drugs of abuse: advantages and pitfalls. -- Abused and designer drugs and how they escape detection. -- Interpretation of amphetamines screening and confirmation testing. -- Clinical false-positive drug test results. -- Providing expert witness for alcohol and positive drugs of abuse test results.
- Handbook of modern pharmaceutical analysis 2001ScienceDirectModern pharmaceutical analysis : an overview / S. Ahuja -- Combinatorial chemistry and high-throughput screening in drug discovery and development / Ken Appell, John J. Baldwin and William J. Egan -- Solid-state analysis / Harry G. Brittain -- Degradation and impurity analysis for pharmaceutical drug candidates / Karen M. Alsante, Robert C. Friedmann, Todd D. Hatajik, Linda L. Lohr, Thomas R. Sharp, Kimberly D. Snyder and Edward J. Szczesny -- Preformulation studies / Edward Lau -- Solid dosage-form analysis / Philip J. Palermo -- Parenteral dosage forms / Gregory A. Birrer, Satya S. Murthy, Jie Liu and Judy Estrada -- New drug delivery systems / David C. Pang -- Compendial testing / Christine F. Richardson -- Method development / Henrik T. Rasmussen -- Setting up specifications / Ian E. Davidson -- Validation of pharmaceutical test methods / Jonathan B. Crowther -- Stability studies / Jessica Cha, Joseph S. Ranweiler and Philip A. Lane -- Analytical methodology transfer / Stephen Scypinski -- Pharmaceutical analysis documentation / Hitesh Chokshi and Kathleen Schostack -- An innovative separation platform : electrophoretic microchip technology / Lian Ji Jin, Jerome Ferrance, Zhili Huang and James P. Landers.
- Handbook of neuroemergency clinical trials 2006ScienceDirectFulltext ScienceDirectAcute ischemic stroke / Christopher Bladin and Stephen Davis -- Subarachnoid hemorrhage / Nader Pouratian, Aaron S. Dumont, and Neal F. Kassell -- Spontaneous intracerebral hemorrhage / Michael D. Hill -- Traumatic brain injury / Wayne M. Alves and Lawrence F. Marshall -- Acute seizures and status epilepticus / Susan Herman -- Clinical trials in neuro-ophthalmology / Madhura Tamhankar and Laura Balcer -- Brain resuscitation / Edwin Nemoto and Charles C. King -- Clinical trials in brain injury after cardiac arrest / Romergryko G. Geocadin and Daniel F. Hanley -- Efficient dose-response finding strategies for acute neuroemergency treatments / Tom Parke ... [et al.] -- Biostatistical issues in neuroemergency clinical trials / Wayne M. Alves -- Data safety and monitoring board: role in acute neurological trials / Brett E. Skolnick -- Role of a project medical officer in acute neuroemergency clinical trials / Joseph A. Kwentus -- Ethical considerations in neuroemergency clinical trials / Wayne M. Alves -- Industry perspective on drug development / Thomas C. Wessel and Christopher Gallen -- Regulatory perspective / Lisa L. Travis.
- Handbook of pharmaceutical analysis by HPLC 2005ScienceDirect
- Handbook of stability testing in pharmaceutical development regulations, methodologies, and best practices 2009Springer
- Helping parents and teachers understand medications for behavioral and emotional problems a resource book of medication information handouts. Fourth edition [4th ed.] 2015PsychiatryOnlineContributors -- Introduction for Clinicians to the Fourth Edition -- Selected Additional Reading for Health and Mental Health Professionals -- Published Resources for Parents and Teachers -- Information on the Internet -- Copyright, Citation, and Disclaimer -- Appendix 1: Medicines With FDA Indication for Attention-Deficit/Hyperactivity Disorder (ADHD) -- Appendix 2: Medicines Typically Used for Anxiety and Depression -- Appendix 3: Medicines Typically Used for Psychosis -- Appendix 4: Medicines Typically Used for Mood Stabilization or Reducing Aggression Drugs by Generic and Brand Names: Alprazolam (Xanax) -- Amitriptyline -- Amphetamine (Dexedrine, ProCentra, Zenzedi, Adderall, Vyvanse) -- Aripiprazole (Abilify) --Asenapine (Saphris) -- Atenolol (Tenormin) -- Atomoxetine (Strattera) -- Benzodiazepines Used for Sleep: Estazolam (ProSom), Flurazepam, Temazepam (Restoril), Triazolam (Halcion) -- Benztropine (Cogentin) -- Bupropion (Wellbutrin, Aplenzin, Forfivo) -- Buspirone -- Carbamazepine (Tegretol, Carbatrol, Epitol, Equetro, Tegretol XR) -- Chlorpromazine -- Citalopram (Celexa) -- Clomipramine (Anafranil) -- Clonazepam (Klonopin) -- Clonidine (Catapres, Catapres-TTS, Kapvay) -- Clozapine (Clozaril, FazaClo, Versacloz) -- Cyproheptadine -- Desipramine (Norpramin) -- Desmopressin Acetate (DDAVP, Stimate) -- Diazepam (Valium) -- Diphenhydramine (Benadryl) -- Duloxetine (Cymbalta) -- Escitalopram (Lexapro) -- Fluoxetine (Prozac, Symbyax) -- Fluphenazine -- Fluvoxamine (Luvox CR) -- Gabapentin (Neurontin, Gralise, Gralise Starter) -- Guanfacine (Tenex, Intuniv) -- Haloperidol (Haldol) -- Hydroxyzine (Vistaril) -- Hypnotics-Sleep Medications (Nonbenzodiazepines): Eszopiclone (Lunesta), Zaleplon (Sonata), Zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) -- Iloperidone (Fanapt) -- Imipramine (Tofranil) -- Lamotrigine (Lamictal, Lamictal XR) -- Levomilnacipran (Fetzima) -- Lithium (Lithobid) -- L-methylfolate (Deplin) -- Lorazepam (Ativan) -- Loxapine (Loxitane, Adasuve) -- Lurasidone (Latuda) -- Melatonin -- Metformin (Glucophage, Glucophage XR, Fortamet, Glumetza, Riomet) -- Methylphenidate (Methylin, Ritalin, Metadate, Concerta, Daytrana, Quillivant, Focalin) -- Mirtazapine (Remeron) -- Modafinil (Provigil), Armodafinil (Nuvigil) -- N-acetylcysteine -- Nortriptyline (Pamelor) -- Olanzapine (Zyprexa, Symbyax) -- Omega-3 Fatty Acids (Epanova, Lovaza) -- Oxcarbazepine (Trileptal, Oxtellar XR) -- Paliperidone (Invega) -- Paroxetine (Paxil, Pexeva, Brisdelle, Paxil CR) -- Perphenazine -- Pimozide (Orap) -- Pindolol -- Prazosin (Minipress) -- Propranolol (Inderal) -- Quetiapine (Seroquel) -- Ramelteon (Rozerem) -- Risperidone (Risperdal) -- Sertraline (Zoloft) -- Thiothixene -- Topiramate (Topamax, Topiragen, Trokendi XR, Qudexy SR) -- Trazodone (Oleptro) -- Trifluoperazine -- Valproic Acid (Depakene, Stavzor), Divalproex (Depakote, Depakote ER, Depakote Sprinkles) -- Venlafaxine (Effexor), Desvenlafaxine (Pristiq, Khedezla) -- Vilazodone (Viibryd) -- Vortioxetine (Brintellix) -- Ziprasidone (Geodon).
- Preface -- Contributors -- ch 1. Ma huang and the ephedra alkaloids / Steven B. Karch -- ch. 2. Kava / Douglas D. Glover -- ch. 3. Ginkgo biloba / Timothy S. Tracy -- ch. 4. Valerian / Brian J. Isetts -- ch. 5. St. John's wort / Dean Filandrinos, Thomas R. Yentsch, and Katie L. Meyers -- ch. 6. Echinacea / Daniel Berkner and Leo Sioris -- ch. 7. Feverfew / Richard L. Kingston -- ch. 8. Garlic / Leslie Helou and Ila M. Harris -- ch. 9. Ginger / Douglas D. Glover -- ch. 10. Saw palmetto / Timothy S. Tracy -- ch. 11. Panax ginseng / Timothy S. Tracy -- ch. 12. Cranberry / Timothy S. Tracy -- ch. 13. Hawthorn / Timothy S. Tracy -- ch. 14. Evening primrose / Margaret B. Artz -- ch. 15. Citrus aurantium / Anders Westanmo -- ch. 16. Vitex agnus-castus / Margaret B. Artz -- ch. 17. Billberry / Timothy S. Tracy -- Index.
- This site features fact sheets on herbs and medicinal plants outlining where each herb is found, what it is used for, how it is used, and any safety concerns and possible drug interaction issues. Also includes publications, presentations, and educational materials on herbs. Searchable. Also available in Spanish. From the University of Texas (UT) at El Paso and UT Austin Cooperative Pharmacy Program.
- High content screening a powerful approach to systems cell biology and drug discovery 2006Springer Protocols
- High throughput bioanalytical sample preparation methods and automation strategies 2003ScienceDirect
- High throughput screening methods and protocols 2002Springer Protocols
- The Good, the bad, and the ugly : a story of two medications -- An Ethical framework -- The Pharmaceutical industry and the free market -- Patents, generic drugs, and academic science -- Research and profits -- Suppression of research data -- The Quality of pharmaceutical research -- The Drug rep: historical background -- The Drug rep today -- The Influence of drug reps: what the data show -- Continuing medical education -- Professional organizations and journal advertising -- The Industry and the consumer -- The FDA: from patent medicines to AIDS drugs -- The FDA and the industry, 1990-2004 -- Solutions: the management and divestment strategies -- Solutions requiring enhanced professionalism in medicine -- Solutions requiring regulatory reform.
- HPLC method development for pharmaceuticals 2007ScienceDirect
- Hydrogen sulfide and its therapeutic applications 2013SpringerThe metabolism of sulfur especially by sulfurtransferases had been intensively studied in mid 1900s. Three enzymes, cystathionine synthase (CBS), cystathionine lyase (CSE) and 3-mercaptopyruvate sulfurtransferase (3MST) were found to have the capacity to produce H2S in vitro. However, H2S was recognized simply as a by-product of the metabolic pathways or as a marker for evaluating the activity of enzymes rather than as a physiological active molecule. In the late 1980s relatively high concentrations of sulfide were measured in the brain that led to the successive studies of identifying the physiological functions of H2S. Recently, the steady-state concentrations of H2S have been re-evaluated and found to be much less than that initially measured. However, despite these differences, such re-evaluations served to further confirm the existence of H2S in mammalian tissues. H2S is produced in almost every organ and plays various roles such as neuromodulation, vasodilation, insulin release, inflammation, angiogenesis and cytoprotection. The unregulated production of H2S and improper responses of target molecules are involved in the pathogenesis of various diseases. This book focuses on these topics as well as on the recent progress in the biology and the therapeutic development of this molecule.
- Ibuprofen is one of the most successful drugs used worldwide for the treatment of mild to moderate pain and various inflammatory conditions, even in a low-dose form for over-the-counter (OTC), non-prescription sale. Over the past 40 years, ibuprofen has been proven to be as safe or safer and just as effective as established non-steroidal anti-inflammatory drugs (NSAIDs) or coxibs. This book reviews the pharmacology, clinical uses and adverse effects of ibuprofen. Its disposition and unique modes of action in relation to clinical effects are discussed as well as various formulations and the impact of food and other variables on its actions and gastro-intestinal safety. The use of combinations of ibuprofen with other drugs (e.g. paracetamol, codeine and caffeine) are critically assessed. There are already some indications of potential therapeutic benefits of the drug combinations in treating certain painful conditions, while still retaining the relative safety benefits of ibuprofen (at least at OTC dosages). The impact of natural products and Chinese Medicines on the safety of ibuprofen is also reviewed. The book is written in a more general style, including explanatory diagrams, for anyone interested in the properties, actions and uses of ibuprofen.
- Identification and quantification of drugs, metabolites and metabolizing enzymes by LC-MS. 1st ed. 2005ScienceDirect
- Imaging in drug discovery and early clinical trials 2005Springer
- Imaging in drug discovery and early clinical trials 2005Springer
- Immunogenicity of biopharmaceuticals 2008Springer
- Immunopharmacology 2008Springer
- Immunotoxicology and immunopharmacology. 3rd ed. 2007CRCnetBASE
- Pattern matching / Scott Markel and Vinodh N. Rajapakse -- Tools for computational protein annotation and function assignment / Jaume M. Canaves -- The impact of genetic variation on drug discovery and development / Michael R. Barnes -- Mining of gene expression data / Aedin Culhane and Alvis Brazma -- Text mining / Bruce Gomes, William Hayes, and Raf Podowski -- Pathways and networks / Eric Minch and Ivayla Vatcheva -- Molecular interactions: learning from protein complexes / Ana Rojas, David de Juan, and Alfonso Valencia -- In silico siRNA design / Darryl León -- Predicting protein subcellular localization using intelligent systems / Rajesh Nair and Burkhard Rost -- Three-dimensional structures in target discovery and validation / Seán I. O'Donoghue, Robert B. Russell, and Andrea Schafferhans -- Comparative genomics / Viviane Siino, Bruce Pascal, and Christopher Sears -- Pharmacogenomics / Bahram Ghaffarzadeh Kermani -- Target identification and validation using human simulation models / Seth Michelson, Didier Scherrer, and Alex L. Bangs -- Using protein targets for in silico structure-based drug discovery / Tad Hurst -- Database management / Arek Kasprzyk and Damian Smedley -- BioIT hardware configuration / Philip Miller -- BioIT architecture: software architecture for bioinformatics research / Michael Dickson -- Workflows and data pipelines / Michael Peeler -- Ontologies / Robin A. McEntire and Robert Stevens.
- Chronic obstructive pulmonary disease (COPD) is a multi-component condition that results in increasingly limited airflow, usually associated with an abnormal inflammatory response of the lung. It constitutes a major public health burden worldwide, while only very few effective therapies are available. This book provides a comprehensive overview of the development of Onbrez Breezhaler, a newly approved once-daily inhaled 2 agonist for the treatment of COPD. It reviews the current pharmacotherapy for COPD and discusses topics such as the chemical design and the pre-clinical pharmacology of the molecule, the early clinical development, the INHANCE study (which provides a successful example of the use of an adaptive design in the confirmatory setting) and the Phase III clinical efficacy study, as well as the history and performance of the Breezhaler device. Finally, a list of emerging targets is included that could well offer future treatment options for COPD.
- Indian medicinal plants an illustrated dictionary 2007Springer
- Industrial pharmaceutical biotechnology 2002Wileych. 1. Introduction to Functional Biotechnology, p. 1-72 -- ch. 2. Organizational Structures, p. 73-76 -- ch. 3. Markets and Factors, p. 77-78 -- ch. 4. Biotechnology and Medicine, p. 79-116 -- ch. 5. Drug Discovery, p. 117-144 -- ch. 6. Molecular Pharma-Biotechnology, p. 145-194 -- ch. 7. Research and Development, p. 195-200 -- ch. 8. Pharmaceutical Production, p. 201-238 -- ch. 9. Safety, p. 239-240 -- ch. 10. Environment, p. 241-243 -- ch. 11. Ethics, p. 245-246 -- ch. 12. Companies, Institutes, Networks, and Organizations, p. 247-261.
- Epidemiology of IGF-1 and cancer / Katharina Nimptsch and Eward Giovannucci -- Aging and cancer : the IGF- I connection / Kalina Biernacka, Claire Perks, and Jeff Holly -- Obesity, type 2 diabetes and cancer / Rosalyn D. Ferguson and Derek LeRoith -- IGF system and breast cancer / Marc A. Becker and Douglas Yee -- The role of insulin-like growth factor signaling in prostate cancer development and progression / Bruce Montgomery, James Dean, and Stephen Plymate -- IGF-1 cellular action and its relationship to cancer : evidence from in vitro and in vivo studies / Rosalyn D. Ferguson ... [et al.] -- Insulin-like growth factor signaling in pediatric sarcomas / Xiaolin Wan, Su Young Kim, and Lee J. Helman -- Cancer genes, tumor suppressors, and regulation of IGF1-R gene expression in cancer / Haim Werner ... [et al.] -- Mouse models of IGF-1R and cancer / Craig I. Campbell, James J. Petrik, and Roger A. Moorehead -- Targeting the insulin-like growth factor-I receptor in cancer therapy / David R. Clemmons -- Targeting insulin-like growth factor receptor 1 (IGF-1R) and insulin receptor signaling by tyrosine kinase inhibitors in cancer / Joan M. Carboni, Mark Wittman, and Fei Huang -- Calories and cancer : the role of insulin-like growth factor-1 / Stephen D. Hursting ... [et al.] -- Cancer cell metabolism / Akash Patnaik, Jason W. Locasale, and Lewis C. Cantley -- Overlaps between the insulin and IGF-I receptor and cancer / Antonino Belfiore and Roberta Malaguarnera.
- Antifungal agents -- Antifungal susceptibility testing: Clinical Laboratory and Standards Institute (CLSI) methods -- Antifungal susceptibility testing methods: non-CLSI methods for yeast and moulds -- Susceptibility testing of dermatophytes -- Usual susceptibility patterns of common yeasts -- Usual susceptibility patterns of common moulds and systemic fungi -- Usual susceptibility patterns for systemic dimorphic fungi -- Utility of antifungal susceptibility testing and clinical correlations.
- Interferon methods and protocols 2005Springer Protocols
- Introduction to pharmacology. 2nd ed. 2003CRCnetBASE
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- Harrison's Principles of Internal Medicine
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