Generic Drug Product Development: Bioequivalence Issues (Hardcover) (ISBN-13: 9780849377846)

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 component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of a bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, this source discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the chemical composition of the active drug and the nature of the drug product..

Author: Isadore Kanfer,Leon Shargel
ISBN-10: 0849377846
ISBN-13: 9780849377846
Publisher: CRC Press
Language: English
Published: 11/15/2007
Pages: 288
Format: Hardcover
Weight: 1.12lbs
Size: 9.04h x 6.41w x 0.75d