Generic Drug Product Development

Solid Oral Dosage Forms, Second Edition

By: Isadore Kanfer (Editor), Leon Shargel (Editor)

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Hardcover | 24 October 2013 | Edition Number 2

At a Glance

Hardcover
398 Pages

Edition Type
New edition

Dimensions(cm)
23.8 x 16.4 x 2.6

Hardcover

RRP $473.00

$403.75

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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.

Industry Reviews

"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

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