[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Notices]
[Page 517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-69]
[[Page 517]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1195]
Draft Guidance for Industry on Bioanalytical Methods Validation
for Human Studies; 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availability of a draft guidance for industry entitled ``Bioanalytical
Methods Validation for Human Studies.'' This draft guidance provides
assistance to sponsors and applicants of investigational new drug
applications (IND's), new drug applications (NDA's), abbreviated new
drug applications (ANDA's), and supplements, in developing validation
information for bioanalytical methods used in human clinical
pharmacology, bioavailability, and bioequivalence studies. This draft
guidance does not cover analytical methods used for nonhuman
pharmacology/toxicology studies, chemistry, manufacturing, and controls
information, or in vitro dissolution studies.
DATES: Written comments may be submitted on the draft guidance document
by March 8, 1999. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of this draft guidance for industry are available on
the Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit
written requests for single copies of ``Bioanalytical Methods
Validation for Human Studies'' 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 Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Vinod P. Shah, Center for Drug
Evaluation and Research (HFD-350), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5635.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Bioanalytical Methods Validation
in Human Studies.'' This draft guidance is based primarily on the
report of a conference on Analytical Methods Validation:
Bioavailability, Bioequivalence and Pharmacokinetic Studies, held on
December 3 to 5, 1990, sponsored by FDA, the American Association of
Pharmaceutical Scientists, Federation Internationale Pharmaceutique,
the Canadian Health Protection Branch, and Association of Official
Analytical Chemists.
This draft level 1 guidance document is being issued consistent
with FDA's good guidance practices (62 FR 8961, February 27, 1997). It
represents the agency's current thinking on bioanalytical methods
validation in human studies. 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 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 are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: December 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-69 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F
