[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Notices]
[Pages 44974-44975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22422]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0331]
Guidance for Industry on Dissolution Testing of Immediate Release
Solid Oral Dosage Forms; 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 for industry entitled ``Dissolution Testing
of Immediate Release Solid Oral Dosage Forms.'' The purpose of this
guidance document is to provide general recommendations for dissolution
testing, approaches for setting dissolution specifications related to
biopharmaceutic characteristics of the drug substance, statistical
methods for comparing dissolution profiles, and a process to help
determine when dissolution testing is sufficient to grant a waiver for
an in vivo bioequivalence study. This guidance document also provides
recommendations for dissolution tests to help ensure continuous drug
product quality and performance after certain postapproval
manufacturing changes.
[[Page 44975]]
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of ``Dissolution
Testing of Immediate Release Solid Oral Dosage Forms'' 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
document to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
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
guidance for industry entitled ``Dissolution Testing of Immediate
Release Solid Oral Dosage Forms.'' The purpose of this guidance
document is to provide: (1) General recommendations for dissolution
testing, (2) approaches for setting dissolution specifications related
to biopharmaceutic characteristics of the drug substance, (3)
statistical methods for comparing dissolution profiles, and (4) a
process to help determine when dissolution testing is sufficient to
grant a waiver for an in vivo bioequivalence study. Three categories of
dissolution test specifications for immediate release drug products are
described in the guidance: (1) Single-point specifications as routine
quality control tests; (2) two-point specifications for characterizing
the quality of the product and as a routine quality control test for
certain types of drug products; and (3) dissolution profile comparison
for accepting product sameness under scale-up and postapproval related
changes (SUPAC), to waive bioequivalence requirements for lower
strengths of a dosage form, and to support waivers of other
bioequivalence requirements.
This document also provides recommendations for dissolution tests
to help ensure continuous drug product quality and performance after
certain postapproval manufacturing changes.
This guidance document represents the agency's current thinking on
the dissolution testing of immediate release solid oral dosage forms.
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 and requests are to be identified with the docket
number found in brackets in the heading of this document. The guidance
document 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.htm.
Dated: August 15, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-22422 Filed 8-22-97; 8:45 am]
BILLING CODE 4160-01-F