Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: 129 (Drugs and the Pharmaceutical Sciences) - Hardcover

Hardcover

ISBN 10: 1420086359 ISBN 13: 9781420086355

Verlag: CRC Press, 2013

Inhaltsangabe

Book by Shargel Leon

Über diesen Titel

Críticas

"Written by experts from academia, industries, and regulatory agency, this is an update of a comprehensive review of the generic oral solid drug product development process. It presents various aspects of generic drug product development with formulation development through to post-approval changes. This edition includes a new chapter on the U.S. Pharmacopeial Convention and its role in harmonization. ... This book will be a standard reference for everyone working on or studying generic drug product development, in industry, academia, and regulatory agency."
―Rahmat M. Talukder, PhD, RPh, West Coast University School of Pharmacy, in Doody's Book Reviews

"This text would be most useful for industry and regulatory professionals, but it would also provide a good reference text for pharmacy students wanting to become familiar with the considerations of generic drug development."
―Emma McConnell, Medical Writer

Reseña del editor

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.

Details zur Ausgabe

• Verlag: CRC Press
• Erscheinungsdatum: 2013
• ISBN 10: 1420086359
• ISBN 13: 9781420086355
• Einband: Tapa dura
• Sprache: Englisch
• Auflage: 2
• Anzahl der Seiten: 397
• Herausgeber: Shargel Leon, Kanfer Isadore