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- Active pharmaceutical ingredients ......
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- Monte Carlo simulation for the pharma...
- — Write it down. 2nd ed. .................
- Monte Carlo simulation for the pharmaceutical industry 2011, CRCnetBASE"Preface Drug development, aiming at improving people's health, becomes more costly every year. The pharmaceutical industry must join its efforts with government and health professions to seek new, innovative, and cost- effective approaches in the development process. During this evolutionary process in the next decades, computer simulations will no doubt play a critical role. Computer simulation or Monte Carlo is the technique of simulating a dynamic system or process using a computer program. Computer simulations, as an efficient and effective research tool, have been used virtually in every concern of engineering, science, mathematics, etc. In this book, I am going to present the concept, theory, algorithm, and cases studies of Monte Carlo simulation in the pharmaceutical and health industries. The concepts refer not only to simulation in general, but also to various types of simulations in drug development. The theory will include virtual data sampling, game theory, deterministic and stochastic decision theories, adaptive design methods, Petrinet, genetic programming, resampling methods, and other strategies. These theories and methods either are necessary to carry out the simulations or make the simulations more efficient, even though there are many practical problems that can be simulated directly in ad hoc fashion without any theory of their efficiency or convergence considerations. The algorithms, which can be descriptive, computer pseudocode, or a combination of both, provide the basis for implementation of simulation methods. The case studies or applications are the simplified versions of the real world problems. These simplifications are necessary because a single case could otherwise occupy the whole book, preventing readers from exploring broad issues"--Provided by publisher.
- Multiple testing problems in pharmaceutical statistics 2010, CRCnetBASE1. Multiplicity problems in clinical trials : a regulatory perspective / Mohammad Huque and Joachim Rèohmel -- 2. Multiple testing methodology / Alex Dmitrienko ... [et al.] -- 3. Multiple testing in dose-response problems / Frank Bretz, Ajit C. Tamhane, and Josâe Pinheiro -- 4. Analysis of multiple endpoints in clinical trials / Ajit C. Tamhane and Alex Dmitrienko -- 5. Gatekeeping procedures in clinical trials / Alex Dmitrienko and Ajit C. Tamhane -- 6. Adaptive designs and confirmatory hypothesis testing / Willi Maurer, Michael Branson, and Martin Posch -- 7. Design and analysis of microarray experiments for pharmacogenomics / Jason C. Hsu ... [et al.].
- Nanoparticulate drug delivery systems 2007, CRCnetBASENanoparticulate drug-delivery systems: an overview / Deepak Thassu, Yashwant Pathak and Michel Deleers -- Nanosuspensions for parenteral delivery / Barrett E. Rabinow -- Nanoparticles prepared using natural and synthetic polymers / Sudhir S. Chakravarthi, Dennis H. Robinson and Sinjan De -- Nanofiber-based drug delivery / Matthew D. Burke and Dmitry Luzhansky -- Drug nanocrystals - the universal formulation approach for poorly soluble drugs / Jan Möschwitzer and Rainer H. Müller -- Lipid-based nanoparticulate drug delivery systems / Jun Wu, Xiaobin Zhao and Robert J. Lee -- Nanoengineering of drug delivery systems / Ashwath Jayagopal and V. Prasad Shastri -- Aerosol flow reactor method for the synthesis of multicomponent drug nano- and microparticles / Janne Raula ... [et al.] -- Supercooled smectic nanoparticles / Heike Bunjes and Judith Kuntsche -- Biological and engineering considerations for developing tumor-targeting metallic nanoparticle drug-delivery systems / Giulio F. Paciotti and Lawrence Tamarkin -- Biological requirements for nanotherapeutic applications / Joseph F. Chiang -- Role of nanobiotechnology in the development of nanomedicine / K.K. Jain -- Pharmaceutical applications of nanoparticulate drug-delivery systems / Yashwant Pathak, Deepak Thassu and Michel Deleers -- Lipid nanoparticles (solid lipid nanoparticles and nanostructured lipid carriers) for cosmetic, dermal, and transdermal applications / Eliana B. Souto and Rainer H. Müller -- Nano-carriers of drugs and genes for the treatment of restenosis / Einat Cohen-Sela ... [et al.] -- Ocular applications of nanoparticulate drug-delivery systems / Annick Ludwig -- Nanoparticulate systems for central nervous system drug delivery / Jean-Christophe Olivier and Manuela Pereira de Oliveira -- Nanoparticles for gene delivery: formulation characteristics / Jaspreet K. Vasir and Vinod Labhasetwar -- Gastrointestinal applications of nanoparticulate drug-delivery systems / Maria Rosa Gasco -- Nanoparticles as adjuvant-vectors for vaccination / Socorro Espuelas ... [et al.] -- Transdermal applications of nanoparticulates / Jongwon Shim.
- New drug development 2004, CRCnetBASE
- Novel antischizophrenia treatments 2012, SpringerThis volume tries to put current therapy - achievements, shortcomings, remaining medical needs - and emerging new targets into the context of increasing knowledge regarding the genetic and neurodevelopmental contributions to the pathophysiology of schizophrenia. Some of the chapters also deal with respective experimental and clinical methodology, biomarkers, and translational aspects of drug development. The volume concentrates on reviewing the ongoing research attempting to identify novel treatments for the cognitive deficits and negative symptoms of schizophrenia, which are not treated adequately by current antipsychotic medications.
- Ophthalmic drug delivery systems. 2nd ed. rev. and expanded 2003, CRCnetBASE
- Ophthalmologic drug guide. 2nd ed. 2011, SpringerAntibacterial agents -- Antifungal agents -- Antiviral agents -- Anti-parasitic agents -- Anti-glaucoma agents -- Neuro-ophthalmology -- Anti-inflammatory agents -- Mydriatics, cycloplegics, and reversal agents -- Lubricants and viscoelastics -- Miscellaneous -- Anti-angiogenesis agents -- Contact lens solutions.
- Parallel imports of pharmaceuticals 2008, Springer
- Parenteral quality control. 3rd ed. 2003, CRCnetBASE
- Percutaneous absorption. 4th ed. 2005, CRCnetBASE
- Percutaneous penetration enhancers. 2nd ed. 2006, CRCnetBASE
- Pharmaceutical biotechnology. 2nd ed. 2006, CRCnetBASE
- Pharmaceutical care 2003, CRCnetBASE
- Pharmaceutical chemical analysis 2006, CRCnetBASE
- Pharmaceutical dissolution testing 2005, CRCnetBASE
- Pharmaceutical engineering change control. 2nd ed. 2004, CRCnetBASE
- Pharmaceutical experimental design and interpretation. 2nd ed. 2006, CRCnetBASEIntroduction to experimental design -- Comparison of mean values -- Nonparametric methods -- Regression and correlation -- Multivariate methods -- Factorial design of experiments -- Response-surface methodology -- Model-dependent optimization -- Sequential methods and model-independent optimization -- Experimental designs for mixtures -- Artificial neural networks and experimental design.
- Pharmaceutical extrusion technology 2003, CRCnetBASE
- Pharmaceutical isothermal calorimetry 2007, CRCnetBASE
- Pharmaceutical photostability and stabilization technology 2006, CRCnetBASE
- Pharmaceutical process scale-up. 2nd ed. 2006, CRCnetBASE
- Pharmaceutical process validation. International 3rd ed., 2003, CRCnetBASE
- Pharmaceutical product strategy 2005, CRCnetBASE
- Pharmaceutical regulatory process 2005, CRCnetBASE
- Pharmaceutical stability testing to support global markets 2010, SpringerContains proceedings of the AAPS Stability Workshop.
- Pharmaceutical statistics using SAS-- a practical guide books24x7, SUNet ID login required. Use Search. Direct Link not yet availableStatistics in drug development by Christy Chuang-Stein and Ralph D'Agostino -- Modern classification methods for drug discovery by Kjell Johnson and William Rayens -- Model building techniques in drug discovery by Kimberly Crimin and Thomas Vidmar -- Statistical considerations in analytical method validation by Bruno Boulanger, Viswanath Devanaryan, Walthère Dewé, and Wendell Smith -- Some statistical considerations in nonclinical safety assessment by Wherly Hoffman, Cindy Lee, Alan Chiang, Kevin Guo, and Daniel Ness -- Nonparametric methods in pharmaceutical statistics by Paul Juneau -- Optimal design of experiments in pharmaceutical applications by Valerii Fedorov, Robert Gagnon, Sergei Leonov, and Yuehui Wu -- Analysis of human pharmacokinetic data by Scott Patterson and Brian Smith -- Allocation in randomized clinical trials by Olga Kuznetsova and Anastasia Ivanova -- Sample-size analysis for traditional hypothesis testing: concepts and issues by Ralph G. O'Brien and John Castelloe -- Design and analysis of dose-ranging clinical studies by Alex Dmitrienko, Kathleen Fritsch, Janson Hsu, and Stephen Ruberg -- Analysis of incomplete data by Geert Molenberghs, Caroline Beunckens, Herbert Thijs, Ivy Jansen, Geert Verbeke, Michael Kenward, and Kristen Van Steen -- Reliability and validity: Assessing the psychometric properties of rating scales by Douglas Faries and Ilker Yalcin -- Decision analysis in drug development by Carl-Fredrik Burman, Andy Grieve, and Stephen Senn.
- Pharmaceutical statistics. 4th ed. 2004, CRCnetBASE
- Pharmaceutical stress testing 2005, CRCnetBASE
- Pharmacoethics 2003, CRCnetBASE
- Pharmacogenomics. 2nd ed. 2005, CRCnetBASEHistorical aspects of pharmacogenetics / Werner Kalow -- Pharmacogenomics and the promise of personalized medicine / Vural Ozdemir and Bernard Lerer -- Pharmacogenetics of drug metabolism: two clinically important polymorphic enzymes, CYP2D6 and TPMT / Georgios Panagiotidis and Leif Bertilsson -- Receptors / Wendell W. Weber -- Pharmacogenetics of drug transporters / Catia Marzolini, Rommel G. Tirona, and Richard B. Kim -- Variability in induction of human drug metabolizing enzymes / Allan B. Okey -- Pharmacogenetics and cardiac ion channels / Dan M. Roden -- Interethnic differences in drug response / Werner Kalow -- Clinical perspectives / Urs A. Meyer and David A. Flockhart -- Regulatory perspectives on pharmacogenomics / Lawrence J. Lesko and Janet Woodcock -- Tools of the trade: the technologies and challenges of pharmacogenetics / Glenn A. Miller -- Technologies for the analysis of single nucleotide polymorphisms - an overview / Denis M. Grant -- Molecular diagnostics / Tracy L. Stockley and Peter N. Ray --
- Pharmacy law and practice. 4th ed. 2006, ScienceDirect
- Photostability of drugs and drug formulations. 2nd ed. 2004, CRCnetBASE
- Polymers in drug delivery 2006, CRCnetBASE
- Preclinical drug development 2005, CRCnetBASE
- Preventing medication errors and improving drug therapy outcomes 2003, CRCnetBASE
- Process of new drug discovery and development. 2nd ed. 2006, CRCnetBASEOverview of the current process of new drug discovery and development / Charles G. Smith and James T. O'Donnell -- Integrated drug product development: from lead candidate selection to life-cycle management / Madhu Pudipeddi, Abu T.M. Serajuddin, and Daniel Mufson -- The impact of combinatorial chemistry on drug discovery / Michael H. Rabinowitz and Nigel Shankley -- High-throughput screening: enabling and influencing the process of drug discovery / Carol Ann Homon and Richard M. Nelson -- Pharmacological and pharmaceutical profiling: new trends / Joanne Bowes ... [et al.] -- Cell-based analysis of drug response using moving optical gradient fields / Jeff M. Hall ... [et al.]. -- Patient-derived primary cells in high-throughput differential antitumor screens: let the patients be the guide / Irwin A. Braude -- The evolving role of the caco-2 cell model to estimate intestinal absorption potential and elucidate transport mechanisms / Jibin Li and Ismael J. Hidalgo -- The promise of metabonomics in drug discovery / Harold J. Kwalwasser and Pauline Gee -- Pharmacogenetics and pharmacogenomics in drug development and regulatory decision-making: report of the first FDA-PWG-PhRMA-druSafe workshop / Lawrence J. Lesko ... [et al.] -- Drugs from molecular targets for CNS and neurodegenerative diseases / William T. Comer and Gönül Veliçelebi -- Safety pharmacology / Jean-Pierre Valentin and Tim G. Hammond -- Nonclinical drug safety assessment / Frederick E. Reno -- Preclinical genotoxicity testing: past, present and future / Richard H.C. San -- The need for animals in biomedical research / Charles G. Smith -- Defining the actual research approach to the new drug substance / Charles G. Smith -- Pharmacokinetics: pharmacodynamics in new drug development / Sarfaraz K. Niazi -- Pharmaceutics and compounding issues in new drug development and marketing / Loyd V. Allen -- Late stage and process development activities / Charles G. Smith -- Contract research organizations: role and function in new drug development / F. Richard Nichol -- The front lines of clinical research: the industry / Lori Nesbitt -- Horizons for cancer chemotherapy (and nonchemotherapy) / Daniel D. Von Hoff -- Human immunodeficiency virus/acquired immune deficiency syndrome: clinical testing challenges / Vincent Idemyor -- Common technical document: the changing face of the new drug application / Justina A. Molzon -- Electronic publishing / Heather L. Wallace -- The important role of pharmacists in a complex risk-management system: managing the risks from medical product use by focusing on patient education, monitoring, and adverse event reporting / Justina A. Molzon -- Liability, litigation, and lessons in new drug development / James T. O'Donnell -- Problems in the nondrug marketplace / Stephen Barrett -- Patents and new product development in the pharmaceutical and biotechnology industries / Henry Grabowski -- The pharmaceutical revolution: drug discovery and development / John C. Somberg -- The discovery of Rituxan / Mitchell E. Reff -- Funding the birth of a drug: lessons from the sell side / Howard E. Greene -- Innovations for the drug development pathway: what is needed now / Janet Woodcock -- Managing R & D uncertainty and maximizing the commercial potential of pharmaceutical compounds using the dynamic modeling framework / Mark Paich ... [et al.].
- Process scale bioseparations for the biopharmaceutical industry 2007, CRCnetBASEHarvest of a therapeutic protein product from high cell density fermentation broths : principles and case study / Elisabeth Russell, Alice Wang, and Anurag S. Rathore -- Expanded bed adsorption for capture from crude solution / Alan Sonnenfeld and Jorg Thommes -- Product recovery by high-gradient magnetic fishing / Matthias Franzreb ... [et al.] -- Protein refolding and scale up / Cynthia Cowgill, Asuman G. Ozturk, and Richard St. John -- Bulk protein crystallization, principles and methods / Mark R. Etzel -- Modes of preparative chromatography / Abhinav A. Shukla and Yinges Yigzaw -- Screening of chromatographic stationary phases / Abhinav A. Shukla and Xuejun Sean Han -- A priori prediction of chromatographic separations from protein structure data / Asif Ladiwala, Curt M. Breneman, and Steven M. Cramer -- Membrane chromatography : analysis of breakthrough curves and viral clearance / Mark R. Etzel and William T. Riordan -- Ultrafiltration process design and implementation / Herb Lutz and Bala Raghunath --Virus filtration process design and implementation / Michael W. Phillips ... [et al.] -- Product recovery from transgenic sources / Chenming (Mike) Zhang and Kevin E. Van Cott -- Analytical strategy for biopharmaceutical development / Drew N. Kelner and Mahesh K. Bhalgat -- Evaluation of viral clearance in purification processes / Amitava Kundu and Karl Reindel -- Advances in viral clearance / Kurt Brorson -- Protein A affinity chromatography for capture and purification of monoclonal antibodies and Fc-fusion proteins: practical considerations for process development / Sanchayita Ghose, Thomas McNerney, and Brian Hubbard -- Polishing methods for monoclonal IgG purification / Pete Gagnon -- Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing : the REMICADE story / Peter W. Wojciechowski ... [et al.] -- Linear scale-up of ultrafiltration of high viscosity process streams / Christopher Daniels ... [et al.] -- A membrane chromatography application : a rapid, high capacity gene therapy vector purification tool / Ajay R. Lajmi, Robert Kutner, and Jakob Reiser.
- Process validation in manufacturing of biopharmaceuticals 2005, CRCnetBASE
- Radiotracers in drug development 2006, CRCnetBASERadiotracers and drug registration -- Radioactivity and radiotracers -- The study of drug metabolism using radiotracers -- DNA binding, isotope dilution and other uses of radiotracers -- Quantitative whole-body autoradiography (QWBA) -- Scintillation counting -- Statistics in liquid scintillation counting -- Instrumentation for detection of radioactivity -- Sample preparation for liquid scintillation counting -- Biomedical accelerator mass spectrometry -- Positron emission tomography -- Gamma scintigraphy and SPECT.
- Rapid microbiological methods in the pharmaceutical industry 2003, CRCnetBASEHistorical perspective on methods development / Anthony M. Cundell -- Microbiological methods of the pharmacopoeia : growth and recovery of microorganisms from pharmaceutical manufacturing environments / Klaus Haberer and Marc W. Mittelmann -- Overview of alternative rapid microbiological technologies / Paul J. Newby and Bob Johnson -- Labor-saving devices and automation of traditional methods / Peter Silley and A.N. Sharpe -- ATP bioluminescence and its use in pharmaceutical microbiology / Kirsty Wills -- Impedance / Peter Silley and Fiona Mortimer -- Traditional and automated rapid methods for species identification and typing / Kevin Tyler and Jeffrey M. Farber -- Techniques for detection of specific organisms and potential for DNA-based technologies / Richard Owen -- Alternative technologies and sterility testing / Amy Meszaros -- Limulus endotoxin test / Thomas J. Novitsky and H. Donald Hochstein -- A practical guide to validation / Kirsty Wills -- Regulatory recognition and acceptance / Edward A. Fitzgerald -- New technologies for microbiological assays / Larry J. Kricka.
- Real world drug discovery. 1st ed. 2008, ScienceDirectThe drug discovery business to date -- The drug discovery business to come -- Industrial considerations -- how things get done : the project team -- Project considerations -- Hit generation -- Turning hits into drugs -- Initial properties -- ADME and PK properties -- Toxicity related properties -- A career in drug discovery research.
- Scale-up and optimization in preparative chromatography 2003, CRCnetBASE
- Six sigma in the pharmaceutical industry 2007, CRCnetBASEThe enormous initial mistake -- The origins of six sigma -- Evolution -- Revolution -- Paradox -- Action and reaction -- Close enough or on target? -- Make more-- faster! -- Case studies -- The camera always lies -- Keeping it simple -- Why use control charts? -- Average and range control charts -- Origins and theory -- Charts for individuals -- Practical considerations -- Improving laboratories -- Beyond compliance.
- Smith and Williams' Introduction to the principles of drug design and action. 4th ed. 2006, CRCnetBASE
- Sociology for pharmacists. 2nd ed. 2003, CRCnetBASE
- Spectroscopy of pharmaceutical solids 2006, CRCnetBASE
- Statistical design and analysis of stability studies 2007, CRCnetBASEIntroduction -- Accelerated testing -- Expiration dating period -- Stability designs -- Stability analysis with fixed batches -- Stability analysis with random batches -- Stability analysis with a mixed effects model -- Stability analysis with discrete responses -- Stability analysis with multiple components -- Stability analysis with frozen drug products -- Stability testing for dissolution -- Current issues and recent development.
- Supercritical fluid technology for drug product development 2004, CRCnetBASE
- Surfactants and polymers in drug delivery 2002, CRCnetBASE
- Synthesis of essential drugs 2006, ScienceDirect
- Systems biology in biotech & pharma 2012, Springer
- Testing computer systems for FDA/MHRA compliance 2004, CRCnetBASE
- Theory and practice of contemporary pharmaceutics 2005, CRCnetBASEMethods of data representation, interpretation, and analysis / Craig K. Svensson and Tapash K. Ghosh -- Thermodynamics and states of matter / Adam M. Persky, Laszlo Prokai, and Jeffrey A. Hughes -- Solubility / Jeffrey A. Hughes .. [et al.] -- Physiochemical factors affecting biological activity / Hemant Alur ... [et al.] -- Micromeritics and rheology / Sunil S. Jambhekar -- Principles and applications of surface phenomena / Laszlo Prokai ... [et al.] -- Theory and applications of diffusion and dissolution / Xiaoling Li and Bhaskara Jasti -- Chemical kinetics and stability / Tapash K. Ghosh -- Drug and dosage form development: regulatory perspectives / Edward Dennis Bashaw -- Oral conventional solid dosage forms: powders and granules, tablets, lozenges, and capsules / Melgardt M. de Villiers -- Oral controlled release solid dosage forms / Emmanuel O. Akala -- Oral liquid dosage forms: solutions, elixirs, syrups, suspensions, and emulsions / William M. Kolling and Tapash K. Ghosh -- Parenteral routes of delivery / Yon Rojanasakul and Carl J. Malanga -- Transdermal and topical drug delivery systems / Bhaskara R. Jasti, William Abraham, and Tapash K. Ghosh -- Rectal and vaginal routes of drug delivery / Nikhil R. Shitut .. [et al.] -- Ocular, nasal, pulmonary, and otic routes of drug delivery / Harisha Atluri ... [et al.] -- Delivery of peptide and protein drugs / Emily Ha ... [et al.].
- Understanding drug release and absorption mechanisms 2007, CRCnetBASEMathematical modeling -- Gastrointestinal tract and skin -- Rheology -- Mass transport -- Drug dissolution and partitioning -- Dissolution of crystallites: size effectson on the solubility -- Drug release from matrix systems -- Drug release from microemulsions -- Drug permeation through membranes.
- Using the pharmaceutical literature 2006, CRCnetBASE
- Validating pharmaceutical systems 2005, CRCnetBASE
- Validation standard operating procedures 2002, CRCnetBASE
- Virtual screening in drug discovery 2005, CRCnetBASE
- Write it down. 2nd ed. 2005, CRCnetBASE
- Harrison's Principles of Internal Medicine
- AAP Red Book Online
- Robbins & Cotran Pathologic Basis of Disease
- Sabiston Textbook of Surgery
- Nelson's Textbook of Pediatrics
- Surgical Exposures in Orthopaedics
- Mandell, Douglas, & Bennett's Principles & Practice of Infectious Diseases
- Red Book Online
- ICU Book
- Primary Care Medicine
- Campbell-Walsh Urology
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