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Date: Thursday, April 17, 2025

Time: 10:00 am – 11:30 am, Japan time

Summary

This educational webinar series will be available only in Japanese.

Research and development of mechanistic drug absorption models are advancing, contributing to the efficient development of new and generic drugs. Certara has developed absorption models in Simcyp Simulator. Some case studies of successful regulatory submissions have used Physiologically-based Biopharmaceutics Model (PBBM) approaches. The authorities start accepting the results of predicting the impact of gastric acid secretion inhibitors on drug absorption.

Close collaboration between CMC, pharmacokinetics, clinical pharmacology, and modeling experts is required to accelerate the more effective use of PBBM. We are delighted to announce that we will provide a series of 4 educational webinars in which those in the CMC department can learn the basics of modeling, and those already using PBPK models can learn the basics of Biopharmaceutics. The agenda of the first course will be ‘The Basics of Drug Absorption in Drug Development – Why is Drug Absorption Essential?’.

Dr. Atsushi Kambayashi from Tokyo University of Science will lecture on the basics of in vitro data analysis and what you need to know to build PBBM models. We hope you will take advantage of this opportunity to learn PBBM in Japanese, from the basics to the application and the Simcyp Absorption Models.

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What will you learn in the course?

  • The role of the physiologically based biopharmaceutics model (PBBM) in pharmaceutical development, formulation development, and new drug applications
  • The basics of drug absorption and bioavailability
  • Understanding membrane permeability

The agenda of the upcoming webinar series

  • Part 2 on July 17th : What is the Drug Absorption Model?
  • Part 3 in November: Understanding the Supersaturated Dissolution in the Digestive Tract with Modeling & Simulation Approaches
  • Part 4 in Jan 2026: Changes in Drug Absorption after Meals and the Reality of Prediction Using Modeling Approaches

The course will be beneficial for:

  • Those who are interested in modeling in the CMC department of a pharmaceutical company
  • Those who want to gain CMC knowledge using PBPK software (Simcyp)

Guest Tutor

Atsushi Kambayashi, PhD

Associate Professor, Tokyo University of Science, Faculty of Pharmaceutical Sciences, Department of Medicinal and Life Sciences

Atsushi Kambayashi, PhD, was a research fellow at Pharmaceutical Research and Technology Laboratories of Astellas Pharma Inc. and currently serves as an associate professor at the Faculty of Pharmaceutical Sciences, Tokyo University of Science.Atsushi has received several prestigious awards, including the 2020 Asahi Kasei Drug Discovery and Development Technology Award from the Academy of Pharmaceutical Science and Technology of Japan and the 2022 ACS Editors’ Choice Article Selection. Additionally, he is an editor for various academic journals, including Pharmaceutics and In Silico Pharmacology.

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