Generic Drug Product Development —— Bioequivalence Issues

----- 非专利药物制品开发：生物等效性

ISBN: 9780849377846 出版年：2007 页码：287 Kanfer, Isadore Shargel, Leon CRC Press

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 comp