Towards a full integration of optimization and validation phases: An analytical-quality-by-design approach-Reference-Cited by-同舟云学术

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Towards a full integration of optimization and validation phases: An analytical-quality-by-design approach

Published:2015-05 Issue: Volume:1395 Page:88-98
ISSN:0021-9673
Container-title:Journal of Chromatography A
language:en
Short-container-title:Journal of Chromatography A

Author:

Hubert C.,Houari S.,Rozet E.,Lebrun P.,Hubert Ph.

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference36 articles.

1. ICH, Q8(R2), Pharmaceutical development, 2009.

2. ICH, Q2(R1), Validation of analytical procedures, 1996.

3. ICH, Q9, Quality risk management, 2006.

4. ICH, Q10, Pharmaceutical quality system, 2008.

5. U.S. Pharmacopeial Convention, chapters 1224, 1225, 1226, USP panel expert.

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