ICHM3(R2) provides guidance under which circumstances and when combination toxicity testing might be needed. Although this seems to be clear and straight forward, there are a number of challenges for these studies, wh...
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ICHM3(R2) provides guidance under which circumstances and when combination toxicity testing might be needed. Although this seems to be clear and straight forward, there are a number of challenges for these studies, which are not covered in the ICH guideline and the relevant Q&A document. Questions that need to be addressed are on species selection for the combo tox study,
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