NCHR Testimony at the Oncologic Drugs Advisory Committee on Dosage Optimization
June 16, 2023: NCHR tested on the January 2023 draft guidance of dosage optimization, showing strong support for the safety and tolerability specifications identified in the draft. We also supported using evaluated population pharmacokinetics data to identify clinically meaningful differences in exposure in specific populations. We urged adding the instructions for using covariants and phenotype data when identifying potential differences in safety or effectiveness for relevant subpopulations to the 2023 guidance. Читать дальше...