[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Draft Guidance for Industry on Bioanalytical Methods Validation 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availability of a draft guidance for industry entitled ``Bioanalytical 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 This draft guidance provides 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 This draft 
guidance does not cover analytical methods used for nonhuman 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DATES: Written comments may be submitted on the draft guidance document 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ADDRESSES: Copies of this draft guidance for industry are available on 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 Submit written comments on the draft guidance to the Dockets 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draft guidance for industry entitled ``Bioanalytical Methods Validation 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 This draft guidance is based primarily on the 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]
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