Using Static and PBPK Models to Assess Potential DDIs, Per FDA Guidance

Life Sciences, Pharmaceutical, Drug Safety, Preclinical,
  • Tuesday, June 16, 2020 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central)
  • 60 min

The FDA recently approved updated regulatory guidance for drug-drug interactions (DDIs). This webinar will focus on how to follow the FDA guidance, design in vitro studies, interpret the data and assess potential drug-drug interactions, using both static and Physiologically Based Pharmacokinetic (PBPK) models.

We will also share our interpretations, as regulatory agencies recommend different approaches for calculation of the DDI potentials including static and PBPK models.

Co-administration of multiple drugs may potentially cause a drug-drug interaction (DDI) in which one drug alters the exposure of another, resulting in either therapeutic failure or risk of a patient’s life. In vitro studies are key to assessing potential DDIs because they are cost-effective, time-saving and can help to understand the mechanisms of DDI and provide directives to clinical trials (clinical trials should not be used to screen potential DDIs because of high costs, lengthy duration and ethical considerations, but they should be used to confirm potential DDIs recommended from in vitro studies and corresponding modeling).

Join this informative webinar on static & PBPK modelling to assess potential DDIs.

Speakers

Gang Luo, Associate Scientific Director, Covance

Dr. Gang Luo has more than two decades of experience in the industry, including nearly a decade at Dupont Pharmaceutical and Bristol-Myers-Squibb (BMS). At Covance, Dr. Luo’s expertise includes general drug metabolism, in vitro metabolism and assessment of drug-drug interactions (DDIs). In addition to nearly 30 peer-reviewed papers and book chapters, Dr. Luo also holds a PhD in Pharmacology from University of Illinois at Chicago and well as post-doctoral trainings from Northwestern University and National Institute of Environmental Health Sciences (NIEHS).

Message Presenter

Mingguang Li, Associate Scientific Director, Covance

Dr. Mingguang Li has more than 13 years of experience in both industry and academia, focusing on advanced pharmacokinetic (PK) and pharmacodynamic (PD) analysis. At Covance, Dr. Li serves as the PK/PD authority to work with clients to assist the drug development from early stage to clinical development. Dr. Li has published more than 15 peer-reviewed articles in scientific journals and two book chapters. He also serves as the peer reviewer for more than 10 high-impact journals. Dr. Li earned his PhD in Pharmaceutical Sciences from Peking University in China.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals with the following or related job titles:

  • Safety pharmacology professionals
  • Heads of preclinical R&D
  • Lead scientists

What You Will Learn

In this webinar, attendees will learn about:

  • Assessment of potential DDIs by in vitro studies
  • Application of the FDA guidance to DDI study design, data interpretation and modelling
  • Understanding of fundamental theories and development strategies of PBPK models
  • Benefits and applications of PBPK models to preclinical drug development and design of first clinical trials

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Covance Inc.

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.

Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.

Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.

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