[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