[Federal Register Volume 64, Number 27 (Wednesday, February 10, 1999)]
[Notices]
[Pages 6663-6664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


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 guidance for industry entitled ``Population 
Pharmacokinetics.'' This guidance provides recommendations to 
pharmaceutical industry scientists, who have long been interested in 
the application of population pharmacokinetics, during the new drug 
development, safety and efficacy evaluation, and approval processes.

DATES: Written comments on the guidance may be submitted at any time. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES:  Copies of this guidance for industry are available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single 
copies of ``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, or the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist the office in processing your 
requests. Copies of this guidance may also be obtained by fax from 1-
888-CBERFAX or 301-827-3844 or by mail from the Voice Information 
System at 800-835-4709 or 301-827-1800. 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.

FOR FURTHER INFORMATION CONTACT: 
    He Sun, Center for Drug Evaluation and Research (HFD-880), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2205, or
    Martin D. Green, Center for Biologics Evaluation and Research (HFM-
579), Food and Drug Administration, 1401 Rockville

[[Page 6664]]

Pike, Rockville, MD 20852, 301-827-5349.

SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
guidance for industry entitled ``Population Pharmacokinetics.'' 
Pharmaceutical industry scientists and FDA have long been interested in 
the application of population pharmacokinetics and pharmacodynamics to 
the evaluation of drug safety and efficacy. Although several special 
data collection and analysis methodologies are available for use, this 
guidance provides recommendations regarding the use of population 
pharmacokinetics in new drug development and evaluation.
    In addition to summarizing the scientific and regulatory issues 
that should be addressed when conducting population pharmacokinetic 
studies and analyses, the guidance: (1) Presents an overview of 
population methods, including when to perform a population study/
analysis; (2) discusses how to design and execute a population 
pharmacokinetic study; (3) describes how to handle and analyze 
population pharmacokinetic data; (4) summarizes what model validation 
methods are available; and (5) explains how to provide appropriate 
documentation for population pharmacokinetic reports intended for 
submission to FDA. Although the information provided in this document 
focuses primarily on population pharmacokinetics, the principles 
discussed are equally applicable to population pharmacodynamic and 
toxicokinetic studies.
    Because population analysis is a rapidly evolving area of drug 
development and regulation, frequent communication throughout the 
entire process between the sponsor and the FDA review staff is 
encouraged.
    In the Federal Register of September 18, 1997 (62 FR 49016), FDA 
announced the availability of a draft version of this guidance entitled 
``Population Pharmacokinetics.'' The September 18, 1997, document gave 
interested persons an opportunity to submit comments through November 
17, 1997. All comments received 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 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 requirements of the 
applicable statute, regulations, or both.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the guidance. 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 guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: February 3, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-3156 Filed 2-9-99; 8:45 am]
BILLING CODE 4160-01-F