Conference Report: The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis

Author:

Abbott Richard W1

Affiliation:

1. Department of Biosciences, Shire Pharmaceuticals, Hampshire International Business Park, Basingstoke, Hampshire, RG24 8EP, UK.

Abstract

The European Bioanalysis Forum is a bioanalytical discussion group comprised of European pharmaceutical companies (27 members to date). The membership share a common vision to advance the shared understanding of topical concerns through discussion of scientific, technological and regulatory issues of bioanalytical interest. The 2nd Annual Open Symposium was much anticipated after the success of the first one. The symposium included sessions on the European Medicines Agency draft bioanalytical guidance, challenges in the analysis and validation of biomarkers, metabolite quantification issues, dried blood spot technology, the analysis of proteins and peptides by MS, latest hot topics in ligand-binding assays, unresolved issues in method validation and a plenary session from the Platinum sponsors. Experts and key opinion leaders were invited as guest speakers. A total of 420 delegates (up from 251 delegates in 2008) attended from 160 organizations, representing a large percentage of the European and international bioanalytical community. In addition to 40 oral presentations, 72 posters were presented and there was a vendor exposition of 35 companies.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference7 articles.

1. Application issues in bioanalytical method validation, sample analysis and data reporting

2. US FDA. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, USA: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, 2001www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf

3. European Medicines Agency concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods. EMA/CHMP/EWP/531305/2008www.ema.europa.eu/pdfs/human/ewp/53130508en.pdf

4. European Medicines Agency draft guideline on validation of bioanalytical methodswww.ema.europe.eu/pdfs/human/ewp/19221709en.pdf

5. EBF and EUFEPS Workshophttp://sites.google.com/site/emeabmv/

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