FDA发布肝功能损伤患者药代动力学研究指南草案并征求意见
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
FDA药品评价与研究中心发布肝功能损伤患者药代动力学研究指南草案，征求意见截止2026年12月1日。草案面向计划开展此类研究的申办者与申请人，涉及肝功能损伤对药物药代动力学及适当情况下药效学的影响。文件列为1级草案，注明不具约束力、暂不供实施，案卷编号为FDA-2026-D-8693。
草案给出肝功能损伤患者药代动力学研究的设计与分析建议，并列出案卷编号和征求意见截止日，便于读者定位待核对内容。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by 12/01/2026
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2026-D-8693
- Docket Number:
- FDA-2026-D-8693
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to sponsors and applicants who plan to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics (PK) and, where appropriate, the pharmacodynamics (PD) of a drug, including therapeutic biological products.
来源：FDA 全域目录：药品／生物制品制造质量指南 · fda.gov