Workshop/Conference Report on EMA Draft Guideline on Validation of Bioanalytical Methods

Author:

Blume Henning,Brendel Erich,Brudny-Klöppel Margarete,Grebe Sylvia,Lausecker Berthold,Rohde Gabriele,Siethoff Christoph

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference10 articles.

1. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules;DeSilva;Pharm Res.,2003

2. Committee for Human Medical Products (CHMP). Guideline on the Investigation of Bioequivalence;European Medicines Agency (EMA),2010

3. Workshop report and follow-up – AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples – implications of crystal city recommendations;Fast;AAPS J.,2009

4. Guidance for Industry: Bioanalytical Method Validation;Food Drug Administration,2001

5. OECD Series on Principles on Good Laboratory Praxis and compliance monitoring (ENV/MC/CHEM(98)17);Organisation for Economic Co-operation development,1998

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