‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances

Author:

Dispas Amandine,Avohou Hermane T.,Lebrun Pierre,Hubert Philippe,Hubert Cédric

Publisher

Elsevier BV

Subject

Spectroscopy,Analytical Chemistry

Reference50 articles.

1. Quality Risk Management;ICH, Q9,2005

2. Q8(R2), Pharmaceutical Development;ICH,2009

3. The application of quality by design to analytical methods;Borman;Pharm. Technol.,2007

4. Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations;Maggio;Trends Anal. Chem.,2013

5. Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process;Hubert;J. Pharm. Biomed. Anal.,2014

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