Andrew G. Taylor, PhD provides an overview of processes by which drugs are metabolized and discusses the importance of drug metabolism and drug-drug interaction studies.

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, often referred to as ADME (Absorption, Distribution, Metabolism, Excretion), 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 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. 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.

Key Topics Include:

  • How drugs are metabolized
  • Safety testing required to move a drug through IND and into clinical trials
  • When to conduct ADME studies in pre-clinical species
  • Common pitfalls and areas of concern: proper design and interpretation

Presenters

Manager of Technical Support for Services
XenoTech

Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego. He joined 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.

Production Partner

XenoTech

XenoTech is a specialty global Contract Research Organization (CRO) specializing in ADME/DMPK/DDI testing of potential drug candidates. Utilized by top pharma companies, biotechs, and numerous other organizations, we provide the finest tools and resources to advance the development of effective, safe drugs. By helping our clients understand as much as possible about their drugs, they have the best chance of getting to clinical trials, and ultimately to the market where patients may benefit. As a premier provider of in vitro drug metabolism and drug-drug interaction studies to pharmaceutical companies worldwide, we have unparalleled experience in evaluating drug candidates as substrates, inhibitors, and inducers of drug-metabolizing enzymes and drug transporters.

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