美國食品藥品管理局（FDA）于2023年9月發(fā)布了“肽類藥物產(chǎn)品臨床藥理學(xué)的考慮的供企業(yè)用的指導(dǎo)原則草案”。該指導(dǎo)原則描述了FDA對肽類藥物產(chǎn)品開發(fā)方案的臨床藥理學(xué)的建議，包括肝損害、藥物-藥物相互作用評估、心電圖按心率校正的QT間期（QTc）延長風(fēng)險評估以及免疫原性風(fēng)險及其對藥動學(xué)、安全性和有效性評估的影響。詳細(xì)介紹FDA該指導(dǎo)原則的主要內(nèi)容，期望對我國肽類藥物產(chǎn)品臨床藥理學(xué)研究和監(jiān)管有所啟示。

Food and Drug Administration (FDA) released the Clinical Pharmacology Considerations for Peptide Drug Products Draft Guidance for Industry in September 2023.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

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