FDA's Clinical Pharmacology Considerations for Peptide Drug Products Draft Guidance for Industry and it's enlightenments
Food and Drug Administration(FDA)released the Clinical Pharmacology Considerations for Peptide Drug Products Draft Guidance for Industry in September 2023.This guidance describes FDA's recommendations regarding clinical pharmacology considerations for peptide drug product development programs,including hepatic impairment,drug-drug interactions,assessing QTc prolongation risk,and immunogenicity risk and impact on the pharmacokinetics(PK),safety,and efficacy assessment.A detailed introduction to the FDA's Guidance is expected to provide inspiration for clinical pharmacology research and regulation of peptide drug products in China.
Food and Drug Administration(FDA)peptide drug productclinical pharmacologyimmunogenicity riskguidance
NETL
NSTL
万方数据
