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.
"This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher.