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M3(R1) - PharmaFacts
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Guidances - ICH Guidances

M3(R1): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

The tripartite harmonized ICH guideline was finalized (Step 4) in July 1997. This multidisciplinary document addresses principles for the development of non-clinical strategies on the timing of toxicity studies in relation to the conduct of clinical trials. The guideline represents an important step forward on requirements for the different phases of clinical development but it is recognized that there remain some further important issues yet to be resolved.

The Guideline has been amended on November 9, 2000, under the Maintenance process.