Generic Drug Product Development Bioequivalence Issues, Vol 180

by Leon Shargel

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 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.

Paperback

First published November 15, 2007