Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

Author:

Kaza Michał,Karaźniewicz-Łada Marta,Kosicka KatarzynaORCID,Siemiątkowska Anna,Rudzki Piotr J.ORCID

Publisher

Elsevier BV

Subject

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

Reference52 articles.

1. Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry;Kadian;J. Pharm. Biomed. Anal.,2016

2. Bioanalytical method development and validation: critical concepts and strategies;Moein;J. Chromatogr. B.,2017

3. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies;Shah;Pharm. Res.,1992

4. A comparison of FDA, EMA, ANVISA, and others on bioanalysis in support of Bioequivalence/ bioavailability studies;Nash,2013

5. Guidance for Industry: Bioanalytical Method Validation;U.S. Food and Drug Administration,2001

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