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

Generic Drug Product Development and Therapeutic Equivalence. Active Pharmaceutical Ingredients.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.