[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Draft Guidance for Industry on Pharmacokinetics and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availability of a draft guidance entitled ``Pharmacokinetics and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 The draft
guidance is intended for sponsors planning to conduct studies to assess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DATES: Written comments may be submitted on the draft guidance by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draft guidance entitled ``Pharmacokinetics and Pharmacodynamics in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