Generic Drug Product Development: Bioequivalence Issues

✍ Scribed by Isadore Kanfer (Author); Leon Shargel (Author)

Publisher: CRC Press
Year: 2007
Leaves: 287
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp

✦ Table of Contents

Introduction - Bioequivalence Issues. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Pharmaceutical Alternatives: Considerations for Generic Substitution. Pharmacodynamic Measurements for Determination of Bioequivalence. Bioequivalence Using Clinical Endpoint Studies. Evaluation of Bioequivalence of Highly-Variable Drug Products. Statistical Considerations: Alternate Designs And Approaches For Bioequivalence Assessments. Population Pharmacokinetic Approaches for Assessing Bioequivalence. Role of Metabolites in Bioequivalence Assessment. Implications of Chirality for the Assessment of Bioequivalence. Effect of Food on Bioavailability and the Assessment of Bioequivalence. Bioequivalence Assessment of Endogenous Drug Substances : Pharmacokinetics and Statistical Evaluation.

✦ Subjects

Bioscience;Pharmaceutical Science;Drug Design & Development;Pharmaceutical Science Regulatory;Engineering & Technology;Manufacturing Engineering;Pharmaceutical Manufacturing

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