Sponsored by Certara
Most therapeutic radiopharmaceutical programs can estimate how much radiation reaches a tumor or organ. The greater challenge is determining whether the selected dose is the optimal one. Increasingly, that is also the question regulators are asking.
Absorbed dose is an important part of the picture, but it cannot determine on its own whether a regimen is optimal, whether organ limits derived from external beam radiation apply to a particular isotope or molecule, or how patient variability may influence safety and efficacy. Sponsors increasingly need an integrated scientific rationale that draws on multiple sources of evidence to support dose selection throughout development.
In this webinar, Certara experts will discuss how clinical pharmacology, dosimetry, pharmacometrics, quantitative systems pharmacology (QSP), and regulatory strategy work together to support dose optimization for therapeutic radiopharmaceuticals. Using practical examples, attendees will learn how integrated quantitative approaches support first-in-human (FIH) dose selection, dose escalation, dose optimization, and regulatory decision-making under Project Optimus.
Key Takeaways: By the end of this webinar you will:
• Understand how Project Optimus and ICH M15 are changing expectations for dose optimization in therapeutic radiopharmaceutical development.
• Explain why absorbed dose is only one part of dose selection and how biologically effective dose (BED), patient variability, and therapeutic index influence dosing decisions.
• Understand how clinical pharmacology, dosimetry, population PK, exposure-response analysis, and QSP work together to support first-in-human dose selection, dose escalation, dose optimization, and regulatory decision-making.
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