United States of America. The Food and Drug Administration has announced the availability of a guidance document entitled "Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/IN Vivo Correlations", which 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 drug product for submission in a new drug application, abbreviated new drug application or antibiotic drug application.
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, manufacturing site changes.
Copies of the guidance may be obtained from the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.
Reference: Federal Register 62(187): 50619 (1997).