Transcription of ICH HARMONISED GUIDELINE
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INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE bioanalytical method validation M10 Draft version Endorsed on 26 February 2019 Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or GUIDELINE , agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. M10 Document History Code History Date M10 Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation (document dated 15/01/2019).
method is suited to the analysis of the study samples. 151. 2.2 Method Validation . 152. 2.2.1 Full Validation 153 Bioanalytical method validation is essential to ensure the acceptability of assay performance 154 and the reliability of analytical results. A bioanalytical method is defined as a set o f procedures
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