Generic drug product development [electronic resource] : solid oral dosage forms
- 2nd ed. - Boca Raton, Fla. : CRC Press/Taylor & Francis Group, 2014.
- Physical description
- xii, 385 p. : ill.
- Drugs and the pharmaceutical sciences ; v. 129.
- Includes bibliographical references and index.
- 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.
- "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.
- Publication date
- edited by Leon Shargel, Isadore Kanfer.
- Drugs and the pharmaceutical sciences ; v. 129
- Also available in print format.
- Mode of access: World Wide Web.
- Available in another form
- 9781420086355 (hardback : alk. paper)