[Federal Register Volume 62, Number 181 (Thursday, September 18, 1997)]
[Notices]
[Page 49016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration
[Docket No. 97D-0383]


Draft Guidance for Industry on Population Pharmacokinetics; 
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availability of a draft guidance for industry entitled ``Population 
Pharmacokinetics.'' This draft guidance is intended to provide 
recommendations regarding the use of population pharmacokinetics in the 
drug development process. It summarizes scientific and regulatory 
issues that should be addressed during the conduct of population 
pharmacokinetic studies/analyses.

DATES: Written comments may be submitted on the draft guidance document 
by November 17, 1997. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance for industry entitled ``Population Pharmacokinetics'' to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send two self-addressed adhesive labels to assist that office 
in processing your request. Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
Request and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the draft 
guidance and received comments are available for public examination in 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.

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, FAX 301-594-2503.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Population Pharmacokinetics.'' 
Population pharmacokinetics is the study of the sources and correlates 
of variability in plasma drug concentrations between individuals, 
representative of those in whom the drug will be used clinically when 
clinically relevant dosage regimens are administered. Certain 
pathophysiological features of patients can regularly alter dose-
concentration relationships. For example, renal failure usually causes 
steady state drug concentrations to be greater than those of patients 
with normal renal function receiving the same dosage of a drug 
eliminated mostly by the kidney. Population pharmacokinetics seeks to 
discover which measurable pathophysiologic factors cause changes in the 
dose-concentration relationship and to what degree so that appropriate 
dosage can be recommended.
    This draft guidance presents a comprehensive overview of population 
methods, including when to perform a population study/analysis; how to 
design and execute population pharmacokinetic studies; how to handle 
and analyze population pharmacokinetic data; how to perform internal 
and external validation of population pharmacokinetic models; and how 
to provide the appropriate documentation for population pharmacokinetic 
reports intended for submission to the FDA.
    This draft guidance represents the agency's current thinking on 
population pharmacokinetics. 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 at http://www.fda.gov/cder/guidance/index.htm.

    Dated: September 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-24733 Filed 9-12-97; 4:34 pm]
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