Read e-book online Handbook of Bioequivalence Testing, Second Edition PDF

By Sarfaraz K. Niazi

ISBN-10: 1482226375

ISBN-13: 9781482226379

ISBN-10: 1482226383

ISBN-13: 9781482226386

Because the popular pharmaceutical keeps to develop and thrive, so does the necessity to behavior sufficient, effective bioequivalence reviews. lately, there were major alterations to the statistical types for comparing bioequivalence. moreover, advances within the analytical know-how used to discover drug and metabolite degrees have made bioequivalence checking out extra complicated. the second one variation of Read more...

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Extra resources for Handbook of Bioequivalence Testing, Second Edition

Sample text

Hundreds of drugs being approved as bioequivalents every year have produced a highly valuable database of what is construed as an approvable protocol; the FDA goes even further and provides a listing of suggested protocols that may be acceptable to the FDA. Sponsors must know that the FDA is never bound by any suggestions or guidelines provided by the FDA, so these protocols serve as a good starting point. The bibliography to this chapter includes an extensive list of the studies reported over the past two years.

703 Nontherapeutic Biomedical Research Involving Human Subjects: Nonclinical Biomedical Research................................................................................................. 704 Principles of ICH GCP.............................................................................................. 704 Institutional Review Board/Independent Ethics Committee.................................... 705 Responsibilities.....................................................................................................

6 Influence of Various Factors on Gastric Emptying in Man.................................... 7 Drug Interactant Influence on Drug Absorption..................................................... 8 Drugs for which First-Pass Hepatic Biotransformation Is Suspected, Possibly in Addition to Gastrointestinal Biotransformation................................................. 9 Drugs that Can Undergo Biotransformation in the Lumen or during Absorption in the Mucosa.......................................................................................

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Handbook of Bioequivalence Testing, Second Edition by Sarfaraz K. Niazi


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