[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]


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

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.

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

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