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FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
FDA issued draft guidance on July 31, 2015 regarding dissolution testing for immediate-release solid oral dosage forms that contain biopharmaceutics classification system (BCS) class 1 and 3 drugs. The guidance, which applies to new drug applications, investigational new drug applications, and/or abbreviated new drug applications, provides recommendations for immediate-release (IR) tablets and capsules that contain highly soluble drug substances.
Specifically, the guidance describes when a standard release test and criteria may be used instead of extensive method development and specification-setting exercises. When finalized, the new guidance will supersede a 1997 guidance, Dissolution Testing for Immediate Release Solid Oral Dosage Forms, for BCS class 1 and 3 drug substances in IR drug products that meet the criteria in the new guidance. The 1997 guidance will still apply for class 2 and 4 drug substances.