Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference

Author:

Yu Lawrence X.,Baker Jeffrey,Berlam Susan C.,Boam Ashley,Brandreth E. J.,Buhse Lucinda,Cosgrove Thomas,Doleski David,Ensor Lynne,Famulare Joseph,Ganapathy Mohan,Grampp Gustavo,Hussong David,Iser Robert,Johnston Gordon,Kesisoglou Filippos,Khan Mansoor,Kozlowski Steven,Lacana Emanuela,Lee Sau L.,Miller Stephen,Miksinski Sarah Pope,Moore Christine M. V.,Mullin Theresa,Raju G. K.,Raw Andre,Rosencrance Susan,Rosolowsky Mark,Stinavage Paul,Thomas Hayden,Wesdyk Russell,Windisch Joerg,Vaithiyalingam Sivakumar

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference24 articles.

1. U. S. Food and Drug Administration. Final report on pharmaceutical cGMPs for the 21st century—a risk-based approach. 2004.

2. U. S. Food and Drug Administration. Guidance for industry: PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. 2004.

3. U. S. Food and Drug Administration. Guidance for industry: Q8(2) pharmaceutical development. 2009.

4. U. S. Food and Drug Administration. Guidance for industry: Q9 quality risk management. 2006.

5. U. S. Food and Drug Administration. Guidance for industry: Q10 pharmaceutical quality system. 2009.

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