The FDA will be hosting a webinar on the ICH M112 guidance:
Date: October 9, 2024
Time: 1:00 PM - 3:00 PM ET
The webinar will discuss ICH M12 which covers Drug Drug Interaction Studies and the assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters.
Topics to be covered include:
- In vitro and clinical assessment of DDIs mediated by:
- CYP and UGT enzymes
- Drug transporters
- Applications of modeling approaches and the utility of endogenous biomarkers
- Data interpretation
- Risk assessment and risk management
Details and a link to Register are available here: https://www.fda.gov/drugs/news-events-human-drugs/ich-m12-drug-drug-interaction-studies-final-guidance-10092024?utm_medium=email&utm_source=govdelivery
#fda #DDI
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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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