[Federal Register: May 23, 2001 (Volume 66, Number 100)]
[Notices]
[Page 28526-28527]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my01-100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1195]
Guidance for Industry on Bioanalytical Method Validation;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Bioanalytical Method
Validation.'' This guidance provides assistance to sponsors of
investigational new drug applications (INDs), new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and their
supplements in developing validation information on bioanalytical
methods for pharmacokinetic (PK) evaluation of human clinical
pharmacology, bioavailability (BA), and bioequivalence (BE) studies.
The guidance also applies to bioanalytical methods used for nonhuman
pharmacology/toxicology studies and preclinical studies. For studies
related to the veterinary drug approval process, this guidance applies
only to blood and urine BA, BE, and PK studies.
DATES: Submit written comments on agency guidances at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), 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 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
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:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Bioanalytical Method Validation.'' This guidance provides
recommendations to sponsors of INDs, NDAs, ANDAs, and their supplements
in developing validation information for bioanalytical methods for PK
evaluations of human clinical pharmacology, BA studies, and BE studies.
The information in this guidance generally applies to bioanalytical
procedures such as gas chromatography (GC), high-pressure liquid
chromatography (LC), combined GC and LC mass spectrometric (MS)
procedures such as LC-MS, LC-MS-MS, GC-MS, GC-MS-MS, and immunological
and microbiological procedures performed for quantitative determination
of drugs and or metabolites in biological matrices such as serum,
plasma, or urine. The guidance also applies to other bioanalytical
matrices such as tissue and skin samples.
In the Federal Register of January 5, 1999 (64 FR 517), FDA
announced the availability of a draft guidance entitled ``Bioanalytical
Methods Validation for Human Studies.'' This January 1999 document gave
interested persons an opportunity to comment through March 8, 1999. The
agency received a total of 36 comments. All comments received
[[Page 28527]]
during the comment period have been carefully reviewed and incorporated
in this revised guidance where appropriate. In addition, a workshop
entitled ``Bioanalytical Method Validation--A Revisit with a Decade of
Progress'' was held January 12 to 14, 2000. This guidance also
incorporates the recommendations from the January 2000 workshop.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000).
The guidance represents the agency's current thinking on the validation
of methods for the assay of drugs and/or metabolites in human
biological matrices. 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 statutes and regulations.
II. Comments
Interested persons may, at any time, submit written comments on the
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 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
Dated: May 11, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12908 Filed 5-22-01; 8:45 am]
BILLING CODE 4160-01-S