Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Hardcover, 2)

Generic Drug Product Development and Therapeutic Equivalence; Leon Shargel and Isadore Kanfer

Active Pharmaceutical Ingredients; Edward M. Cohen and Steven Sutherland

Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms; Quanyin Gao and Dilip R. Sanvordeker

Experimental Formulation Development; Isadore Kanfer, Roderick B. Walker, Raimar Lobenberg, and Nadia Araci Bou-Chacra

Scale-up, Technology Transfer, and Process Performance Qualification; Salah U. Ahmed, Ashok Katdare, Venkatesh Naini, and Dilip Wadgaonkar

Drug Stability; Pranab K. Bhattacharyya

Quality Control and Quality Assurance; Loren Gelber

Drug Product Performance: In Vitro; Pradeep M. Sathe, John Duan, and Lawrence X. Yu

ANDA Regulatory Approval Process; Timothy W. Ames and Aaron Sigler

Bioequivalence and Drug Product Assessment: In Vivo; Barbara M. Davit and Dale P. Conner

Statistical Considerations for Establishing Bioequivalence; Charles Bon and Sanford Bolton

Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations; Patrick K. Noonan

Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences; Lorien Armour and Leon Shargel

The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization; William Brown and Margareth R. C. Marques

Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing; Arthur T. Tsien

Index