Generic Drug Product Development —— Specialty Dosage Forms

----- 非专利药物制品开发：特殊药物制品

ISBN: 9780849377860 出版年：2016 页码：292 Shargel, Leon Kanfer, Isadore CRC Press

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru