FDA “肽类药物产品临床药理学的考虑的供企业用的指导原则草案” 及其启示

美国食品药品管理局（FDA）于2023年9月发布了“肽类药物产品临床药理学的考虑的供企业用的指导原则草案”。该指导原则描述了FDA对肽类药物产品开发方案的临床药理学的建议，包括肝损害、药物-药物相互作用评估、心电图按心率校正的QT间期（QTc）延长风险评估以及免疫原性风险及其对药动学、安全性和有效性评估的影响。详细介绍FDA该指导原则的主要内容，期望对我国肽类药物产品临床药理学研究和监管有所启示。

FDA's Clinical Pharmacology Considerations for Peptide Drug Products Draft Guidance for Industry and it's enlightenments

Food and Drug Administration (FDA) released the Clinical Pharmacology Considerations for Peptide Drug Products Draft Guidance for Industry in September 2023.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.