Reliability of simulated robustness testing in fast liquid chromatography, using state-of-the-art column technology, instrumentation and modelling software

Author:

Kormány Róbert,Fekete Jenő,Guillarme Davy,Fekete Szabolcs

Publisher

Elsevier BV

Subject

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

Reference35 articles.

1. Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation;Monks;J. Chromatogr. A,2012

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005), http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.

3. Validating Chromatographic Methods;Bliesner,2006

4. Ruggedness and robustness testing;Dejaegher;J. Chromatogr. A,2007

5. Guidance for robustness/ruggedness tests in method validation;Vander Heyden;J. Pharm. Biomed. Anal.,2001

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