Isadore Kanfer, Leon Shargel

Generic Drug Product Development (eBook, ePUB)

Bioequivalence Issues

• Format: ePub

Produktbeschreibung

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

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 288
• Erscheinungstermin: 15. November 2007
• Englisch
• ISBN-13: 9781040168998
• Artikelnr.: 72531968

Autorenporträt

Isadore Kanfer, Leon Shargel

Inhaltsangabe

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.