ch. 1. Generic drug product development and therapeutic equivalence / Leon Shargel and Isadore Kanfer -- ch. 2. Active pharmaceutical ingredients / Edward M. Cohen and Steven Sutherland -- ch. 3. Analytical methods development and methods validation for oral solid dosage forms / Quanyin Gao and Dilip R. Sanvordeker -- ch. 4. Experimental formulation development / Isadore Kanfer. [et al.] -- ch. 5. Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed. [et al.] -- ch. 6. Drug stability / Pranab K. Bhattacharyya -- ch. 7. Quality control and quality assurance / Loren Gelber -- ch. 8. Drug product performance : in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ch. 9. ANDA regulatory approval process / Timothy W. Ames and Aaron Sigler -- ch. 10. Bioequivalence and drug product assessment : in vivo / Barbara M. Davit and Dale P. Conner -- ch. 11. Statistical considerations for establishing bioequivalence / Charles Bon and Sanford Bolton -- ch. 12. Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- ch. 13. Postapproval changes and postmarketing reporting of adverse drug experiences / Lorien Armour and Leon Shargel -- ch. 14. The United States pharmacopeia/national formulary : its history, organization, and role in harmonization / William Brown and Margareth R.C. Marques -- ch. 15. Legal and legislative hurdles to generic drug development, approval, and marketing / Arthur Y. Tsien.