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Documents American Pharmaceutical Review Barnes Et Al

1. In Process Monitoring of Polymorphic Form Conversion by Raman Spectroscopy and Turbidity Measurements Susan Barnes, Jason Gillian, Ann Diederich, Delphi Burton, Darryl…

Technology Design Space

1. Case Study:Implementation of Design Space Concepts in Development of an Active-Coated Tablet Robert A. Lipper, Ph.D., Divyakant Desai, Ph.D., San Kiang, Ph.D. Bristol-Myers…

Documents ONDQA Perspective on Post Approval Changes Eric P. Duffy, PhD Director, Division of Post-Market...

Slide 1 ONDQA Perspective on Post Approval Changes Eric P. Duffy, PhD Director, Division of Post-Market Evaluation, ONDQA, CDER, FDA Public Meeting: Supplements and Other…

Documents Introduction to Topic #1: QbD approach for quality control and assurance of Dissolution Rate Ajaz S....

Introduction to Topic #1: QbD approach for quality control and assurance of Dissolution Rate Ajaz S. Hussain, Ph.D. Deputy Director, Office of Pharmaceutical Science, CDER,…