PBPK Modeling to Support Clinical DDI Studies
Sponsored by: Covance
Date: 31 October
Time: 2PM London/10AM New York
Applications & Advances
Statistics from the FDA’s NDA submissions over the past ten years show a significant increase in cases that include physiologically based pharmacokinetic (PBPK) modeling supporting the design of clinical studies evaluating drug-drug interactions (DDI). Regulatory agencies, including the FDA and EMA, have strongly recommended that drug developers include PBPK modeling to support clinical DDI studies and both have published guidance for regulating PBPK modeling recently (in 2018 and 2016, respectively). However, due to the complexity of development, PBPK modeling is still a challenge for many companies.
This webinar will help you to understand the current status of PBPK modeling and applications in clinical studies, focusing on drug-drug interactions.
You can expect
• A detailed and in-depth demonstration of PBPK modeling approaches.
• Summaries of the guidance and recommendations from regulatory agencies for using PBPK modeling to support clinical DDIs.
• Descriptions of the studies and experiments needed to develop PBPK models (including in vitro metabolism and ADME).
• An exploration into when PBPK modeling would be most beneficial or critical to include.
• Case study reviews.
Associate Scientific Director, PK/PD Modeling & Simulation
With more than 13 years of experience in both industry and academia, focusing on advanced pharmacokinetic (PK) and pharmacodynamic (PD) analysis, Dr. Li serves as the PK/PD authority to assist clients from preclinical to clinical at Covance. Dr. Li has published over 15 peer-reviewed articles in scientific journals and two book chapters, and 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.
Key Learning Objectives
- Understand the concept of PBPK and its application in clinical DDI studies
- Be able to make decisions on when to perform PBPK modeling before clinical studies
- Know which data is necessary to collect for PBPK modeling
- Gain perspective into current and future trends of PBPK modeling
- Scientists and leaders in pharmacokinetics; in clinical pharmacology; and in translational sciences