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

This is a summary report of the workshop on the EMA Draft Guideline on Validation of Bioanalytical Methods held April 15–16th 2010 in Brussels (Belgium) and jointly organised by the European Bioanalysis Forum (EBF) and the European Federation for Pharmaceutical Sciences (EUFEPS). Aim of the workshop...

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Bibliographic Details
Published in:European journal of pharmaceutical sciences 2011-02, Vol.42 (3), p.300-305
Main Authors: Blume, Henning, Brendel, Erich, Brudny-Klöppel, Margarete, Grebe, Sylvia, Lausecker, Berthold, Rohde, Gabriele, Siethoff, Christoph
Format: Article
Language:English
Subjects:
Analysis
Bioanalytical
Chemistry, Pharmaceutical
Chromatographic
EMA
GLP
Guideline
Guidelines as Topic
Ligand-binding
Validation
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Summary:This is a summary report of the workshop on the EMA Draft Guideline on Validation of Bioanalytical Methods held April 15–16th 2010 in Brussels (Belgium) and jointly organised by the European Bioanalysis Forum (EBF) and the European Federation for Pharmaceutical Sciences (EUFEPS). Aim of the workshop was to discuss the current scientific knowledge in the area of bioanalysis, the regulatory requirements with special focus on the new Draft Guideline and their subsequent implementation to the work in bioanalytical laboratories. Comments on the Draft Guideline were presented and discussed with representatives from regulatory authorities in Europe. The workshop started with discussions on the scope of the Guideline and the need for implementation of GLP. A special focus was set on method validation of chromatographic procedures and subsequent study sample analysis. In addition, requirements for ligand-binding assays were briefly addressed. Intention of this Conference Report is to summarise important aspects of the discussions in order to draw certain conclusions, and to identify points which remain open and may require clarification at a later stage.
ISSN:0928-0987
1879-0720
DOI:10.1016/j.ejps.2010.12.008