Generic Drug Product Development
Bioequivalence Issues
Published on 15. November 2007
288 pages
978-1-040-16899-8 (ISBN)
Description
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
More details
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
Professional and scholarly
File size
4,29 MB
ISBN-13
978-1-040-16899-8 (9781040168998)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Book
11/2007
1st Edition
CRC Press
€252.30
Shipment within 15-20 days
Persons
Content
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.
