[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Pages 28526-28527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12908]


-----------------------------------------------------------------------

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://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