Expanding the term “Design Space” in high performance liquid chromatography (I)-Reference-Cited by-同舟云学术

Expanding the term “Design Space” in high performance liquid chromatography (I)

Published:2011-12 Issue:5 Volume:56 Page:874-879
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Monks K.E.,Rieger H.-J.,Molnár I.

Publisher

Elsevier BV

Subject

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

Reference23 articles.

1. L.R. Snyder, J.L. Glajch, Computer-assisted Method Development for High-performance Liquid Chromatography, Elsevier, Amsterdam, 1990 (also J. Chromatogr. 485 (1989)).

2. ICH Q8 – Guidance for Industry, Pharmaceutical Development, 2006.

3. ICH Q9 – Quality Risk Management, 2006.

4. ICH Q10 – Pharmaceutical Quality System, 2009.

5. M. Nasr, CDER, FDA, Lecture on “Quality by Design (QbD): Analytical Aspects” at HPLC 2009, Dresden, Germany, September 2009.

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