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.
- 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.
- (source: Nielsen Book Data)
- Publisher's Summary
- In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products-from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: * Active pharmaceutical ingredients * Experimental formulation development, including a new section on Quality by Design (QbD) * Scale-up * Commercial product formulation * Quality control and bioequivalence * Drug product performance * ANDA regulatory process * Post-approval changes * Post-marketing surveillance * Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
(source: Nielsen Book Data)
- 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)
- 9781420086362 (e-book : PDF)
- 1420086367 (electronic bk.)