Application of the QbD Principles in the Development of the Casopitant Mesylate Manufacturing Process. Process Research Studies for the Definition of the Control Strategy of some Drug Substance-CQAs for Stages 2a, 2b, and 2c

Author:

Cimarosti Zadeo1,Bravo Fernando1,Castoldi Damiano1,Tinazzi Francesco1,Provera Stefano1,Perboni Alcide1,Papini Damiano1,Westerduin Pieter1

Affiliation:

1. Chemical Development, Medicines Research Center, GlaxoSmithKline, Verona, Italy, and Molecular Discovery Research, Medicines Research Center, GlaxoSmithKline, Verona, Italy

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference6 articles.

1. ICH Q8 Pharmaceutical Development;

2. ICH Q9 Quality Risk Management;

3. ICHQ 10 Pharmaceutical Quality System.

4. See for example:Pharmaceutical cGMPs for the 21st century - A risk based approach,Final Report;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Silver Spring, MD, U.S.A., 2004.

5. Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance

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