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Surrogate matrix: opportunities & challenges for tissue sample analysis Review


October 1994. This identifies the validation parameters needed for a variety of analytical methods. The tripartite harmonised ICH Guideline on Methodology (previously coded Q2B) was finalized under Step 4 in November 1996. It extends the Guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures. The Guideline on Methodology has been incorporated into the Guideline on Text in November 2005 and then renamed Q2(R1), without any changes in the contents of the two Guidelines.


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49 Hubert P, Nguyen-Huu JJ, Boulanger B et al. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal: part IV. Examples of application. J. Pharm. Biomed. Anal. 48(3), 760–771 (2008).


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