Analytical Method Quality by Design for an On-Line Near-Infrared Method to Monitor Blend Potency and Uniformity

Author:

Corredor Claudia C.,Lozano Ruben,Bu Xin,McCann Ryan,Dougherty Jeffrey,Stevens Tim,Both Douglas,Shah Pankaj

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Reference36 articles.

1. FDA/International Conference on Harmonisation (ICH) Q8: guidance for industry pharmaceutical development. 2009.

2. FDA/International Conference on Harmonisation (ICH) Q9: quality risk management. 2005.

3. FDA/International Conference on Harmonisation (ICH) Q10: pharmaceutical quality system. 2008.

4. Orlandini S, Pinzauti S, Furlanetto S. Application of quality by design to the development of analytical separation methods. Anal Bioanal Chem. 2012;405:443–50.

5. Vogt FG, Kord AS. Development of quality-by-design analytical methods. J Pharm Sci. 2011;100:797–812.

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