In early August, FDA issued a draft guidance on āDissolution Testing and Specification Criteria for Immediate-Release SolidĀ Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.ā The draft guidance was developedĀ to provide manufacturers with recommendations for submission of new and abbreviated new drug applications (NDA andĀ ANDAs) and investigational new drug applications (INDs) for immediate-release (IR) tablets and capsules that containĀ highly soluble drug substances. It describes when a standard release test and criteria may be used in lieu of extensive methodĀ development and specification-setting exercises. Comments are due by October 2, 2015. When final, this guidance will supersedeĀ the guidance for industry on āDissolution Testing of Immediate Release Solid Oral Dosage Forms,ā which was issued in AugustĀ 1997 for Biopharmaceutics Classification System (BCS) Class 1 and 3 drug substances in immediate-release drug products thatĀ meet the criteria in the guidance. For class 2 and 4 drug substances, applicants should still refer to the August 1997 guidance.
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