FDA (CDER)
GUIDANCE DRAFT
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Published: 9/2/2026Detected: 9/4/2026
Summary preview
Clarifies how pharmacokinetic studies in patients with impaired hepatic function should be designed and analyzed to support labeling recommendations, with an emphasis on translating PK findings into dosing adjustments.
Get the full analysis, free
Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.
Create free accountclinical
safety
labeling
gastroenterology
#pharmacokinetics
#hepatic impairment
#dose adjustment
#labeling
#Child-Pugh
Official Source Document Source Verified
Access the original document directly from FDA CDER.
More from FDA (CDER)
- E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility10/1/2026
- Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for Industry9/8/2026
- Evaluation of Therapeutic Equivalence8/21/2026
- Determining Whether to Submit an ANDA or a 505(b)(2) Application8/17/2026
- Container Closure Systems for Human Drugs and Biological Products8/13/2026