Home » Generic Drug Product Development: Bioequivalence Issues by Leon Shargel
Generic Drug Product Development: Bioequivalence Issues Leon Shargel

Generic Drug Product Development: Bioequivalence Issues

Leon Shargel

Published November 15th 2007
ISBN : 9780849377846
Hardcover
264 pages
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 About the Book 

To be interchangeable with the brand name alternative, generic pharmaceutical products must demonstrate that they are its therapeutic equivalent. This title focuses on bioequivalence issues and alternate approaches to demonstrate bioequivalence ofMoreTo be interchangeable with the brand name alternative, generic pharmaceutical products must demonstrate that they are its therapeutic equivalent. This title focuses on bioequivalence issues and alternate approaches to demonstrate bioequivalence of generic drugs. Exploring scientific, legal, and international regulatory challenges, this source discusses the use of alternative approaches to measure plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed based upon the chemical component of the drug.