Expectations of the US-FDA regarding dissolution data in generic drug regulatory submissions
Posted on April 17, 2013
By: Barbara M. Davit, Director of the Division of Bioequivalence II; Ethan Stier, Deputy Director of the Division of Bioequivalence II; Xiaojian Jiang, Team Leader in the Division of Bioequivalence II; Om Anand, Senior Reviewer in the Division of Bioequivalence II
Office of Generic Drugs, Center for Drug Evaluation and Research, US-FDA
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 7520 Standish Place, Rockville, Maryland 20855, USA.
Introduction Dissolution testing plays a critical role in the approval of safe and effective generic drug products in the United States (US). In most Abbreviated New Drug Applications (ANDAs) for solid dosage forms, the investigator is expected to develop and submit a validated, reproducible and di...
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Related Topics and Keywords
bioequivalence, Dissolution testing, FDA, HPLC, solid oral dosage forms
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