Quality by Design (QbD) and the Development and Manufacture of Drug Substance

Author:

Steele Gerry1

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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