Abstract
INTRODUCTION In late 2009 the GSK R&D Product Development organization began implementing a new approach to calibration of dissolution test equipment, specifically Apparatus 1 and 2 (baskets and paddles). The new approach, enhanced mechanical calibration (EMC), which was recommended by FDA, follows the ASTM International Standard Procedure ASTM 2503-07 (1). This article explains why this change was made, what was done to effect the change, how it was accomplished, and things we learned in the process.
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