From the document:
Objective
This guideline provides recommendations to promote a consistent approach in designing,
conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug
interaction (DDI) studies during the development of a therapeutic product. A consistent approach
will reduce uncertainty for the pharmaceutical industry to meet the requirements of multiple
regulatory agencies and lead to more efficient utilization of resources. In addition, this approach
will lead to the effective and safe treatment for patients who take multiple medications.
Link to ICH M12
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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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