Transcription of Guideline Bioanalytical method validation
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Guideline Bioanalytical method validation
Superseded30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 21 July 2011 EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** Committee for Medicinal Products for Human Use (CHMP) Guideline on Bioanalytical method validation Draft agreed by the Efficacy Working Party September 2009 Adoption by CHMP for release for consultation 19 November 2009 End of consultation (deadline for comments) 31 May 2010 Agreed by Pharmacokinetics Working Party (PKWP) June 2011 Adoption byCHMP21 July 2011 Date for coming into effect 1 February 2012 *The corrections concern: Section Accuracy (p.)
During method validation and analysis of study samples, a blank biological matrix will be spiked with the analyte(s) of interest using solutions of reference standard(s) to prepare calibration standards, quality control samples and stability sa mples. In …
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