[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Pages 32617-32618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0214]


Draft Guidance for Industry on Pharmacokinetics and 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availability of a draft guidance entitled ``Pharmacokinetics and 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 The draft 
guidance is intended for sponsors planning to conduct studies to assess 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

DATES: Written comments may be submitted on the draft guidance by 
August 15, 1997. General comments on the agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of 
``Pharmacokinetics and Pharmacodynamics 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 and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. 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

[[Page 32618]]

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.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance entitled ``Pharmacokinetics and Pharmacodynamics in 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/PD characterization may need to be 
assessed in subjects with such impairment to provide appropriate dosing 
recommendations.
    The draft 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/PD studies in patients with impaired renal function, the design 
and conduct of PK/PD studies in end stage renal disease (ESRD) patients 
treated with hemodialysis, the analysis and reporting of the results of 
such studies, and representation of these results in approved product 
labeling.
    This draft guidance represents the agency's current thinking on 
conducting PK/PD 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 submit written comments on the draft 
guidance to the Dockets Management Branch (address above). Two copies 
of any 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 draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.
    An electronic version of this draft guidance is available on the 
Internet using the World Wide Web (www) at http://www.fda.gov/cder/
guidance.htm.

    Dated: June 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-15635 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F