Description: Generic Drug Product Development : Bioequivalence Issues, Hardcover by Kanfer, Isadore; Shargel, Leon, ISBN 0849377846, ISBN-13 9780849377846, Brand New, Free P&P in the UK 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 bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, 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 physical and chemical properties of the active drug and the nature of the drug product.
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Book Title: Generic Drug Product Development : Bioequivalence Issues
Number of Pages: 288 Pages
Publication Name: Generic Drug Product Development: Bioequivalence Issues
Language: English
Publisher: Taylor & Francis INC International Concepts
Item Height: 229 mm
Subject: Business
Publication Year: 2007
Type: Textbook
Item Weight: 499 g
Subject Area: Chemical Engineering
Author: Isadore Kanfer, Leon Shargel
Item Width: 152 mm
Format: Hardcover
