Here you can edit and choose your personal newsletter preferences and skip topics you’re not interested in.
(you can choose as many as you want!)
Translational PK Modeling and First-in-Human Design
State-of-the-art pharmacokinetic modeling tools are being used to support internal and regulatory decision making throughout drug development process. In the last years, the use of pharmacokinetic modeling and simulation allow:
- expedite drug development process
- Support internal decisions
- Support regulatory decisions
- Substantially reduce the costs of drug development process
Have a question? We got all the answers
Issues to be covered
- Introduction to modeling: empirical and physiological based modeling
- fit-for-purpose modeling: how to choose the right modeling approach
- Modeling for Small molecules (ADME, DDI, alternative route of administration) vs. biologics (target interaction, membrane-bound vs. soluble and target mediated disposition)
- Model informed drug development for internal and regulatory decision making
- Practice modeling using state of the art open-source software
The participants will have free access (during the course and afterward) to web-based applications for PK analysis
Who should attend
- R&D scientists from the academic, pharmaceutical industry and biotech in non-clinical and clinical stages
- Clinical leaders (clinical pharmacology, clinical development)
- Statisticians with the will to gain knowledge in the field of PK and drug developmen
Prerequisite:
Basic PK knowledge, theoretical and/or practical.
Benefits to the Participants
- Acquaintance with modeling and simulation approaches
- Pros and cons of each modeling and simulation approach.
- Appropriate use of modeling to support non-clinical and clinical development of small molecules and biologics
- How to leverage modeling and simulations to support regulatory decision-making and expedite drug development process
- How to de-risk transition from non-clinical to clinical drug development
About The Lecturer
