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Generics and Bioequivalence provides a clear, insightful, and in-depth analysis of the many complex issues encountered in the determination of drug bioequivalence. Included are timely updates on many controversial and newly emerging areas in the design and analysis of bioavailability and bioequivalence studies. This new reference was prepared by a group of authorities from academe, industry, and government and can be easily understood by students and experienced scientists alike. Topics presented include the role of single and multiple dosing in the determination of bioequivalence, the role of metabolites in assessing bioequivalence, stereochemical considerations in bioequivalence evaluation, uses of animal models, pharmacodynamics, and statistics. The analysis of pharmacodynamic data (especially when plasma levels are unavailable) is covered, and the nascent importance of individual bioequivalence is examined.
Hardcover: 224 pages
Publisher: CRC Press (June 23, 1994)
Language: English
ISBN-10: 0849369304
ISBN-13: 978-0849369308
Product Dimensions: 0.8 x 6.8 x 9.8 inches
Shipping Weight: 1.6 pounds
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Best Sellers Rank: #6,681,209 in Books (See Top 100 in Books) #96 in Books > Medical Books > Pharmacology > Pharmacodynamics #3522 in Books > Textbooks > Medicine & Health Sciences > Allied Health Services > Pharmacy #5507 in Books > Textbooks > Medicine & Health Sciences > Medicine > Basic Sciences > Pharmacology
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