In early August, FDA issued a draft guidance on “Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.” The draft guidance was developed to provide manufacturers with recommendations for submission of new and abbreviated new drug applications (NDA and ANDAs) and investigational new drug applications (INDs) for immediate-release (IR) tablets and capsules that contain highly soluble drug substances. It describes when a standard release test and criteria may be used in lieu of extensive method development and specification-setting exercises. Comments are due by October 2, 2015. When final, this guidance will supersede the guidance for industry on “Dissolution Testing of Immediate Release Solid Oral Dosage Forms,” which was issued in August 1997 for Biopharmaceutics Classification System (BCS) Class 1 and 3 drug substances in immediate-release drug products that 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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