Quality by Design (QbD) and the Development and Manufacture of Drug Substance
Author:
Affiliation:
1. PharmaCryst Consulting Ltd; Loughborough United Kingdom
Publisher
John Wiley & Sons, Ltd
Reference117 articles.
1. Process R&D Under the Magnifying Glass: Organization, Business Model, Challenges, and Scientific Context;Federsel;Bioorg Med Chem,2010
2. Early Chemical Development at Legacy Wyeth Research;O'Brien;Drug Discovery Today,2011
3. Understanding ICH Q11-FDA's Guidance on the Development and manufacturing of Drug Substances;Mehta;Pharm Tech,2013
4. Quality by Design: Perspectives on the Current Status of Implementation and Challenges for the Future;Broadhead;GMP Rev,2013
5. Understanding and Controlling the Formation of an Impurity During the Development of Muraglitazar, a PPAR Dual Agonist;Ye;Org Process Res Dev,2008
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