European Medicines Agency Guideline on Bioanalytical Method Validation: What More Is There to Say?
2012; Future Science Ltd; Volume: 4; Issue: 8 Linguagem: Inglês
10.4155/bio.12.44
ISSN1757-6199
Autores Tópico(s)Statistical Methods in Clinical Trials
ResumoBioanalysisVol. 4, No. 8 CommentaryEuropean Medicines Agency guideline on bioanalytical method validation: what more is there to say?Graeme SmithGraeme SmithDepartment of Bioanalysis, Huntingdon Life Sciences, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK. Published Online:26 Apr 2012https://doi.org/10.4155/bio.12.44AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: bioanalytical method validationEuropean Medicines Agencyguidance for industryguidelineUS FDAReferences1 EBF and EUFEPS Workshop on: EMEA Draft Guideline on Validation of Bioanalytical Methods. Brussels, Belgium, 15–16 April 2010.Google Scholar2 Amsterdam PV. How to implement the EMA Guideline on bioanalytical method validation. Presented at: EBF 4th Open Symposium. Barcelona, Spain, 16–18 November 2011.Google Scholar3 Viswanathan CT, Bansal S, Booth B et al. 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This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download
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