Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance-Reference-Cited by-同舟云学术

Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance

Published:2010-05 Issue:5 Volume:2 Page:929-935
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Smith Graeme¹

Affiliation:

1. Scientific Director, Department of Bioanalysis, Huntingdon Life Sciences, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK.

Publisher

Future Science Ltd

Subject

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

Link

http://www.future-science.com/doi/pdf/10.4155/bio.10.42

Reference5 articles.

1. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

2. Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

3. US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD, USA (2001)www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070107.pdf

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

5. European Medicines Agency. Draft Guideline on Validation of Bioanalytical Methods. EMEA/CHMP/EWP/192217/2009 (2009)www.ema.europa.eu/pdfs/human/ewp/19221709en.pdf

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