Translational PK Modeling and First-in-Human Design

Conducted by: Dr. Raphael Bilgraer, Dr. David Bibi
SKU: 221085
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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
R&D are using the state-of-the-art pharmacokinetic modeling to optimize the...Continue reading

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

R&D are using the state-of-the-art pharmacokinetic modeling to optimize the transition from non-clinical to clinical stage of drug development (small molecules and biologics) and expedite drug development process.
These pharmacokinetic modeling and simulations are useful tools to support internal and regulatory decision-making and expedite drug development process.
The objective of this course is to optimize the transition from non-clinical to clinical stage of drug development (small molecules and biologics) using state-of-the-art pharmacokinetic modeling and simulation approaches. The attendees will learn how to leverage modeling and simulations to support regulatory decision-making and expedite drug development process

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Dates: 
  • 08/09/2022
  • 15/09/2022
  • 22/09/2022
Course location: Zoom Course
Duration: 3 sessions (3.5 hours each)
Hours: 09:00 - 12:30
Credits: 1
Course Language: עברית

Course price: ₪2,900 + VAT
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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

Raphael Bilgraer
Dr. Raphael Bilgraer, pharmacometrician and clinical pharmacology and pharmacometrics at
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David Bibi
Dr. David Bibi, DMPK project leader, non-clinical development at Teva
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