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Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: A case of a learning process

  • Published:2014-01 Issue: Volume:88 Page:401-409
  • ISSN:0731-7085
  • Container-title:Journal of Pharmaceutical and Biomedical Analysis
  • language:en
  • Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

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

Funder

Walloon Project PPP

Walloon Project CWALITY

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference28 articles.

1. ICH, Q1A(R2), Stability testing of new drug substances and products (2003).

2. ICH, Q3B(R2), Impurities in new drug products (2006).

3. FDA, Code of Federal Regulations, Title 21, Section 211, Current good manufacturing practice for finished pharmaceuticals (Rockville, MD, 2012).

4. The role of analytical chemistry in drug-stability studies;Görög;Trends Anal. Chem.,2013

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