While ICH released M12 in May, FDA has just released ICH M12 Drug Interaction Studies Guidance and the Q&A Companion document:
https://www.fda.gov/media/161199/download
https://www.fda.gov/media/180488/download
#fda #ICH #M12 #DrugInteraction
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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