Selecting the right dose for a therapeutic radiopharmaceutical requires more than understanding how much radiation reaches a tumor or organ. Sponsors need an integrated scientific rationale that connects dosimetry with clinical pharmacology, patient variability, safety, efficacy, and regulatory expectations.
In this on-demand webinar, Certara experts explore how clinical pharmacology, dosimetry, pharmacometrics, quantitative systems pharmacology (QSP), and regulatory strategy can work together to strengthen dose optimization throughout therapeutic radiopharmaceutical development.
Through practical examples, learn how integrated quantitative approaches can support first-in-human dose selection, dose escalation, dose optimization, and regulatory decision making.
Watch the webinar to learn:
- How Project Optimus and ICH M15 are shaping expectations for dose optimization in therapeutic radiopharmaceutical development
- Why absorbed dose alone may not provide the full picture for selecting an optimal regimen
- How biologically effective dose, patient variability, and therapeutic index can inform dosing decisions
- How clinical pharmacology, dosimetry, population PK, exposure-response analysis, and QSP can work together across development
- How model-informed approaches can help build a stronger scientific and regulatory rationale for dose selection
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Speakers:
- Amandine Manon, PharmD
Senior Director, Clinical Pharmacology and Translational Medicine - Diane-Charlotte Imbs, PharmD, PhD
Director Clinical Pharmacology, Drug Development Solutions - Joshuaine Grant
Senior Director, Quantitative Systems Pharmacology (QSP) - Hunter Stephens, PhD
Associate Director, Pharmacometrics - Mirjam Trame, PharmD, PhD
Vice President, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II
