Director, Pharmacometrics & System Pharmacology Pfizer, United States
Disclosure(s): No financial relationships to disclose
Disclosure(s):
Rudy Gunawan, PhD: No financial relationships to disclose
Population pharmacokinetic (popPK) and exposure-response modeling can help guide optimization of drug exposure through model-driven balance of expected key efficacy and safety endpoints. For ADCs with shorter half-lives, schedule optimization with more frequent dose regimens may allow a higher dose intensity of ADC to be administered and optimize key pharmacokinetic parameters (AUC and Ctrough) to improve the benefit-risk profile. Pharmacometric-based approaches such as PK-TGI (tumor growth inhibition) models for efficacy, along with time to event or Markov models for safety endpoints, can be used to support dose optimization for ADCs.
