Dissolution Testing of Immediate Release Solid Oral Dosage Forms

This guidance is developed for immediate release (IR) dosage forms and is intended to provide  (1) general recommendations for dissolution testing; (2) approaches for setting dissolution specifications related to the 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. This document also provides recommendations for dissolution tests to help ensure continuous drug product quality and performance after certain postapproval manufacturing changes. Summary information on dissolution methodology, apparatus, and operating conditions for dissolution testing of IR products is provided in summary form in Appendix A. This guidance is intended to complement the SUPAC - IR guidance for industry: Immediate Release Solid Oral Dosage Forms: Scale-up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, with specific reference to the generation of dissolution profiles for comparative purposes.