Best Practices for Building and Applying PBPK Models to Support DDI Assessment + Industrial Case Study
  • Past
  • 9:30 – 11:30 am BJT
  • Online (Beijing, China)

Join us for an immersive webinar to learn best practices for building and applying PBPK models in GastroPlus® to confidently predict DDIs and inform regulatory decisions. The workflows implemented at Simulations Plus to validate standard DDI models will be discussed, and the application of GastroPlus to waive DDI studies will be illustrated using a real industrial case study where GastroPlus DDI projections were used in lieu of clinical studies. In this case study, a drug metabolized via the CYP3A pathway was evaluated for potential interactions with weak/moderate CYP3A inducers and inhibitors. The projections and GastroPlus files were submitted to health authorities to inform the drug label and are currently under regulatory review.

A live Q&A will follow to give attendees the opportunity to gain additional insights from the expert speakers.

Please note that to access the webinar, you will need a WeChat account.

Course Outline 

  • Part 1: Introduction to GastroPlus DDI Module
  • Part 2: Industrial Case Study

Presenters

Revathi Chapa
Revhathi is a Senior Scientist at Simulations Plus where she is involved in the development of PBPK models for various applications such as first in human predictions, food effect, PK in special populations, Drug-Drug Interactions, etc.

Jasmina Novakovic
Jasmina has been a Principal Scientist at Simulations Plus since April 2019. In her current role, Jasmina supports clients’ projects employing PBPK modeling and simulations.