Quality by design for biopharmaceuticals principles and case studies (Wiley, 2009)
Includes bibliographical references and index
Wiley Series in Biotechnology and bioengineering. Anurag S. Rathore, Series Editor. Quality by Design for Biopharmaceuticals. Principles and Case Studies. Edited by. Anurag S. Rathore. Rohin Mhatre. The concepts, applications, and practical issues of Quality by Design. Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into