[Federal Register Volume 68, Number 104 (Friday, May 30, 2003)]
[Notices]
[Page 32531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13477]



[[Page 32531]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-5047]


Guidance for Industry on Pharmacokinetics in Patients With 
Impaired Hepatic Function: Study Design, Data Analysis, and Impact on 
Dosing and Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Pharmacokinetics in 
Patients With Impaired Hepatic Function: Study Design, Data Analysis, 
and Impact on Dosing and Labeling.'' This guidance provides 
recommendations to sponsors planning to conduct studies to assess the 
influence of hepatic impairment on the pharmacokinetics and, where 
appropriate, the pharmacodynamics of drugs or therapeutic biologics.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Mehul U. Mehta, Center for Drug Evaluation and Research (HFD-860), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-2567; or
    David Green, Center for Biologics Evaluation and Research (HFM-
579), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-5349.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Pharmacokinetics in Patients With Impaired Hepatic Function: 
Study Design, Data Analysis, and Impact on Dosing and Labeling.'' This 
document provides guidance on: (1) When pharmacokinetic studies in 
patients with hepatic impairments should be conducted; (2) the 
recommended design and conduct of studies to characterize the effects 
of impaired hepatic function on the pharmacokinetics of a drug; (3) 
inclusion criteria for patient populations to be studied; (4) analysis, 
interpretation, and reporting of the results of the studies; and (5) 
the description of study results in drug labeling.
    In the Federal Register of December 7, 1999 (64 FR 68357), FDA 
published a notice announcing the availability of a draft version of 
this guidance. A number of comments were received in the docket for the 
1999 draft guidance. After careful consideration of the comments, the 
draft guidance was revised. Although we made a number of clarifying 
edits and tried to make the guidance more user friendly, the only 
substantive change to the draft guidance was to correct the implication 
that certain drugs should be studied in patients with concurrent 
hepatic and renal impairment.
    This level 1 final guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The guidance 
represents the agency's current thinking on pharmacokinetic studies in 
patients with impaired hepatic function. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13477 Filed 5-29-03; 8:45 am]
BILLING CODE 4160-01-S