QUALITY BY DESIGN

Author:

am Ende Mary T.1,Seymour Christine B.2

Affiliation:

1. Process Modeling & Engineering Technology Group; Pfizer Inc.; Groton CT USA

2. Global Regulatory Affairs CMC; Pfizer Inc.; Groton CT USA

Publisher

John Wiley & Sons, Inc.

Reference10 articles.

1. International Conference on Harmonisation: guidance on Q8(R1) Pharmaceutical Development;FDA;Federal Register,2009

2. International Conference on Harmonisation: guidance on Q9 Quality Risk Management;FDA;Federal Register,2006

3. International Conference on Harmonisation: guidance on Q10 Pharmaceutical Quality System;FDA;Federal Register,2009

4. Pickett , J. 2007 Inspection Monitor CMC pilot program succeeding in integrating concepts of QbD: Nasr

5. Morris , W. Hough , E. 2008 Parenteral Drug Association (PDA) Newsletter QbD pilot program for biotech seeks similar answers as one for small molecules

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