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Are in vitro metabolism and DDI studies critical for an IND?

Sekisui XenoTech

Presenter: Greg Loewen, Director of Technical Support at SEKISUI XenoTech

Continuing our ADME 101 presentation series assisting researchers and industry professionals with navigating ADME, DMPK, and DDI within the complex landscape of drug development, Greg Loewen presented on whether in-vitro metabolism and drug-drug interaction (DDI) studies are critical for an IND at the 2019 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, PharmSci 360, in San Antonio, TX.

Drug metabolism and DDI studies often take a back seat to toxicity studies when preparing for an IND. Cross species metabolite identification and plasma protein binding are typically considered sufficient for an IND. However, benefits to drug development efficiency and expense along with modern regulatory expectations are causing many to look deeper earlier.

Metabolism studies can help bridge in vivo data to clinical outcomes. Furthermore, recent guidance documents from regulatory bodies indicate that DDI studies should be done before clinical studies. Lastly, when is the appropriate time to conduct ADME studies in pre-clinical species?

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about 7 months ago

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