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



February 25, 2022

Presenter: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services 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, Dr. Taylor presented on whether in-vitro metabolism and drug-drug interaction (DDI) studies are critical for an IND to the American Association of Pharmaceutical Scientists (AAPS) in January 2022. 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. 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, guidance documents from regulatory bodies indicate that DDI studies should be done before clinical studies. So when is the appropriate time to conduct ADME (Absorption, Distribution, Metabolism, Excretion) studies in pre-clinical species? This talk will discuss processes for the metabolism of a drug, referred to as ADME, and the safety testing to provide requisite information to move a drug through IND and into clinical trials. Prior to marketing a new drug and actually prior to administering a candidate drug to humans in clinical trials, it is important to ensure that drug will not only be effective in the therapeutic manner prescribed, but also be safe and not bring any undo harm to patients. How a drug is metabolized is one of the most important aspects to understand. If you are involved in the development of potential new therapeutics, this discussion will help you gain necessary knowledge to inform your drug development decisions. Download a copy of the slides: Questions, comments and requests: More information on our research services and test systems: Other previously aired webinars: Upcoming webinar notifications: Request a webinar topic: About the Presenter: Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego, Scripps Institution of Oceanography. He joined SEKISUI XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies compliance with Good Laboratory in Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met.

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