本オンライン講座は日本語による講演です。
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.
本講座で学べる内容
- 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
対象者
- 製薬企業のCMC部門でモデリングに興味がある方
- PBPKソフトウェア(Simcyp)を活用したCMCの知識を得たい方
