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  • Book
    Lawrence X. Yu, Bing V. Li, editors.
    Summary: This 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.

    Contents:
    1 Bioequivalence History
    2 Fundamentals of Bioequivalence
    3 Basic Statistical Considerations
    4 The Effects of Food on Drug Bioavailability and Bioequivalence
    5 Bio waiver and Biopharmaceutics Classification System
    6 Bioequivalence of Highly Variable Drugs
    7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
    8 Bioequivalence for Narrow Therapeutic Index Drugs
    9 Pharmacodynamic Endpoint-based Bioequivalence Studies
    10 Clinical Endpoint Bioequivalence Study
    11 Bioequivalence for Liposomal Drug Products
    12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract
    13 Bioequivalence for Topical Drug Products
    14 Bioequivalence for Orally Inhaled and Nasal Drug Products
    15 Bioequivalence: Modeling and Simulation
    16 Bioanalysis.
    Digital Access Springer 2014
  • Other
    Séverine Auffret, lu par l'auteur.
    Summary: Essays on sex discrimination and practices against women.
    Print [1988?]
  • Article
    Brook I, Pettit TH, Martin WJ, Finegold SM.
    Ann Ophthalmol. 1979 Mar;11(3):389-93.
    Aerobic and anaerobic cultures and clinical data were obtained from 131 patients presenting with acute conjunctivitis. Similar cultures were obtained from 60 noninflamed individuals. Anaerobes were isolated from 66 patients, 51 times in mixed culture with aerobes and 15 times (11.5%) as the only isolates. Aerobes only were recovered in 54 patients. The organisms found to be statistically significantly more commonly recovered from eyes with conjunctivitis were Staphylococcus aureus, Hemophilus influenzae, Peptostreptococcus, and Propionibacterium acnes. No statistical difference was present between the bacterial flora of the eyes with unilateral conjunctivitis when compared to their uninvolved mates in 20 cases in which only one eye was involved.
    Digital Access Access Options