Bibliography
- Dadgar D , BurnettPE, ChocMG, GallicanoK, HooperJW. Application issues in bioanalytical method validation, sample analysis and data reporting. J. Pharm. Biomed. Anal. 13(2), 89–97 (1995).
Websites
- 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, 2001 www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf
- European Medicines Agency concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods. EMA/CHMP/EWP/531305/2008 www.ema.europa.eu/pdfs/human/ewp/53130508en.pdf
- European Medicines Agency draft guideline on validation of bioanalytical methods www.ema.europe.eu/pdfs/human/ewp/19221709en.pdf
- EBF and EUFEPS Workshop http://sites.google.com/site/emeabmv/
- US FDA. Guidance for Industry: Safety Testing of Drug Metabolites www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079266.pdf#6
- Connecting strategies on dried blood spots http://sites.google.com/site/ebfdbs/