[Federal Register Volume 62, Number 187 (Friday, September 26, 1997)]
[Notices]
[Page 50619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25514]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0398]


Guidance for Industry on Extended Release Oral Dosage Forms: 
Development, Evaluation, and Application of In Vitro/In Vivo 
Correlations; 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 document for industry entitled ``Extended 
Release Oral Dosage Forms: Development, Evaluation, and Application of 
In Vitro/In Vivo Correlations.'' This guidance document is intended to 
provide recommendations to pharmaceutical sponsors who intend to 
develop documentation in support of an in vitro/in vivo correlation 
(IVIVC) for an oral extended release (ER) drug product for submission 
in a new drug application (NDA), abbreviated new drug application 
(ANDA), or antibiotic drug application (ANDA/AADA).

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of ``Extended 
Release Oral Dosage Forms: Development, Evaluation, and Application of 
In Vitro/In Vivo Correlations'' 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 guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Ramana Uppoor, Center for Drug 
Evaluation and Research, HFD-860, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5305.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance document for industry entitled ``Extended Release Oral Dosage 
Forms: Development, Evaluation, and Application of In Vitro/In Vivo 
Correlations.'' This guidance document provides recommendations to 
pharmaceutical sponsors who intend to develop documentation in support 
of an IVIVC for an oral ER drug product for submission in an NDA, ANDA, 
or AADA. The guidance presents a comprehensive perspective on: (1) 
Methods of developing an IVIVC and evaluating its predictability; (2) 
using an IVIVC to set dissolution specifications; and (3) applying an 
IVIVC as a surrogate for in vivo bioequivalence when it is necessary to 
document bioequivalence during the initial approval process or because 
of certain preapproval or postapproval changes, e.g., formulation, 
equipment, process, and manufacturing site changes.
    This guidance document represents the agency's current thinking on 
the development, evaluation, and application of in vitro/in vivo 
correlations for an oral ER drug product for submission in an NDA, 
ANDA, or AADA. 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 
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 may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.
    An electronic version of this guidance is also available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm.

    Dated: September 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25514 Filed 9-25-97; 8:45 am]
BILLING CODE 4160-01-F