Generic Drug Product Development PDF
By:Leon Shargel,Isadore Kanfer
Published on 2013-10-24 by CRC Press
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.
This Book was ranked at 30 by Google Books for keyword Product Development.
Book ID of Generic Drug Product Development's Books is 1SUAAQAAQBAJ, Book which was written byLeon Shargel,Isadore Kanferhave ETAG "yb5sTRfeH9g"
Book which was published by CRC Press since 2013-10-24 have ISBNs, ISBN 13 Code is 9781420086355 and ISBN 10 Code is 1420086359
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Book which have "397 Pages" is Printed at BOOK under CategoryMedical
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