From Physiological based Pharmacokinetics (PBPK) Modelling to First-in-Human Dose
Predict safe and effective first in human doses and drug-drug interactions (DDIs)
Accurate human dose prediction remains one of the most critical and complex decisions in early drug development. As molecule modalities diversify and regulatory expectations evolve, reliance on empirical scaling alone is no longer sufficient. Integrating mechanistic PBPK approaches with established industry practices is increasingly essential to reduce uncertainty and improve translation from preclinical data to the clinic.
Why Watch This Webinar?
Selecting the right first in human (FIH) dose requires more than empirical scaling. In this expert-led session, discover how mechanistic PBPK models combined with accepted industry approaches support informed, confident human dose selection across modalities.
What You’ll Learn
- Understanding the differences between empirical pharmacokinetic models and physiologically based pharmacokinetic (PBPK) models
- How PBPK models predict human pharmacokinetics using in vitro and preclinical data
- Applications of PBPK in drug–drug interaction assessment and special populations
- Standard industry approaches for first-in-human (FIH) dose prediction
- Integrating allometric scaling and PBPK insights
- Practical challenges and considerations in human dose selection
Speakers and Moderator Panel
Speaker: Dr. Claire Wilson
Claire brings over 25 years of drug discovery experience, contributing across target ID, optimization, and Phase 1 evaluation. She has held key scientific roles at Syneos Health, Galderma, and Evotec, and holds a PhD focused on time‑dependent P450 inhibition.
Speaker: Dr. M. Surulivel Rajan
Dr. Rajan has 25+ years of expertise in clinical pharmacokinetics, population PK modelling, and pharmacotherapy. With 80+ publications, he has guided numerous PhD and PharmD scholars and leads national initiatives in pharmacometrics through SOPHAS and APN.
Moderator: Dr. Amol Raje
Amol brings 24+ years of DMPK experience across 30+ discovery targets and multiple therapeutic areas. He has worked on diverse modalities, including small molecules, biologics, PROTACs, ADCs, and peptides. He contributed to two NCEs reaching the Indian market, one NCE in the Phase 3 clinical trials, and five clinical candidate nominations. Amol has 20+ publications and holds a PhD degree in Pharmacokinetics.
