Generic Drug Product Development: Specialty Dosage Forms

by Leon Shargel and Isadore Kanfer

Book Overview

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 drug products to brand name alternatives.

The contributors discuss measurement...

• Format: Hardcover
• Language: English
• ISBN: 0849377862
• ISBN13: 9780849377860
• Release Date: March 2010
• Publisher: CRC Press
• Length: 288 Pages
• Weight: 1.15 lbs.
• Dimensions: 0.9" x 6.1" x 9.1"