[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Notices]
[Pages 27094-27095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0214]


Guidance for Industry on Pharmacokinetics in Patients with 
Impaired Renal 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 Renal Function--Study Design, Data Analysis, and 
Impact on Dosing and Labeling.'' The guidance is intended for sponsors 
planning to conduct studies to assess the influence of renal impairment 
on the pharmacokinetics of an investigational drug.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this guidance are available on the Internet at 
``http://www.fda.gov/cder/guidance/index.htm'', or ``<a href="http://
www.fda.gov/cber/guidelines.htm">http://
www.fda.gov/cber/guidelines.htm</a>''. Submit written requests for single 
copies of ``Pharmacokinetics in Patients with Impaired Renal Function--
Study Design, Data Analysis, and Impact on Dosing and Labeling'' to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food

[[Page 27095]]

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or 
Office of Communication, Training and Manufacturers Assistance (HFM-
40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by calling 1-
800-835-4709 or 301-827-1800. Submit written comments on the guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Shiew-Mei Huang, Center for Drug Evaluation and Research (HFD-850), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-5671; or
    Martin D. Green, Center for Biologics Evaluation and Research (HFM-
579), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-5344.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance entitled ``Pharmacokinetics in Patients with Impaired Renal 
Function--Study Design, Data Analysis, and Impact on Dosing and 
Labeling.''
    The pharmacokinetics (PK) and pharmacodynamics (PD) of drugs 
primarily eliminated through the kidneys may be altered by impaired 
renal function to the extent that the dosage regimen needs to be 
changed from that used in patients with normal renal function. Although 
the most obvious type of change arising from renal impairment is a 
decrease in renal excretion (or possibly renal metabolism) of a drug or 
its metabolites, renal impairment also has been associated with other 
changes, such as changes in hepatic metabolism, plasma protein binding, 
and drug distribution. These changes may be particularly prominent in 
patients with severely impaired renal function and have been observed 
even when the renal route is not the primary route of elimination of a 
drug. Thus, for most drugs that are likely to be administered to 
patients with renal impairment, PK characterization may need to be 
assessed in subjects with such impairment to provide appropriate dosing 
recommendations.
    The guidance provides specific information on when studies of PK in 
patients with impaired renal function should be performed and when they 
may be unnecessary. It also addresses the design and conduct of PK 
studies in patients with impaired renal function, the design and 
conduct of PK studies in end stage renal disease patients treated with 
dialysis, the analysis and reporting of the results of such studies, 
and representation of these results in approved product labeling.
    In the Federal Register of June 16, 1997 (62 FR 32617), FDA 
announced the availability of a draft version of this guidance, 
entitled ``Pharmacokinetics and Pharmacodynamics in Patients with 
Impaired Rental Function: Study Design, Data Analysis, and Impact on 
Dosing and Labeling.'' The June 16, 1997, document gave interested 
persons an opportunity to submit comments through August 15, 1997. All 
comments received through the end of September have been carefully 
reviewed and incorporated, where appropriate, in this revised guidance.
    This guidance is being issued as a Level 1 guidance consistent with 
FDA's good guidance practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on conducting PK studies on 
patients with impaired renal 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 requirement of the applicable statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Comments 
should be identified with the docket number found in brackets in the 
heading of this document. A copy of the guidance is available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

    Dated: May 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-12898 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F