title: Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance.
authors.affiliation: Department of Bioanalysis, Huntingdon Life Sciences, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK. smithg@ukorg.huntingdon.com
authors.forename: Graeme
authors.initials: G
authors.lastname: Smith
mesh_terms: D000818:Animals; D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D005060:Europe; D006077:Government Agencies / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D008024:Ligands; D057230:Limit of Detection; D012015:Reference Standards; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D008024:Ligands