New US FDA Draft Guidance on Bioanalytical Method Validation Versus Current FDA and EMA Guidelines: Chromatographic Methods and Isr

10.4155/bio.13.19

10.1208/aapsj0901004

10.1208/s12248-009-9100-9

10.4155/bio.11.239

10.4155/bio.12.54

10.4155/bio.11.121

10.4155/bio.13.157

10.4155/bio.10.90

US FDA. Guidance for Industry: Bioanalytical Method Validation (2013). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf

US FDA. Guidance for Industry: Bioanalytical Method Validation (2001). www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070107.pdf

European Medicines Agency. Guideline on bioanalytical method validation (July 2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf

Reflection Paper for Laboratories That Perform the Analysis or Evaluation of Clinical Trial Samples. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/09/WC500096987.pdf

Global Bioanalysis Consortium: Team A2 – Tiered Approaches to Method Validation. www.globalbioanalysisconsortium.org/site/gbc/assets/documents/HT%20slide%20decks/GBC%20Team%20A-2%20for%20upload.pdf