2019 AAPS PharmSci 360

2019 AAPS PharmSci 360

Sunday, November 3, 2019

Visit us at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, PharmSci 360, booth 1206 on Nov. 3-6th in San Antonio, TX. Greg Loewen will be presenting on "Are in-vitro metabolism and DDI studies critical for an IND?" on Monday, November 4th from 9-10 AM in Partner Presentation Classroom 4...

Presentation Description: Drug metabolism and drug-drug interaction (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. 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 appropriate time to conduct an ADME study in a pre-clinical species?

If you cannot attend this presentation, you may want to consider our ACT Meeting presentation2020 SOT course or you can request a webinar.

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