论文信息 - Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests

Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests

As part of its evaluation of the performance verification tests used periodically to affirm the integrity of the USP Performance test when General Chapter Dissolution is relied upon, the Biopharmaceutics Expert Committee of the Council of Experts, working with staff, decided to change the form of the accept/reject decision from one based on the result for each tablet to one based on the mean and coefficient of variation of results from a set of tablets. This paper describes the new approach. The paper also describes an implementation period for the approach, coupled with a period during which USP will discontinue use of the Salicylic Acid tablet in a performance verification test.

[1] Guide to the use of repeatability , reproducibility and trueness estimates in measurement uncertainty estimation , 2002 .

[2] Todd L. Cecil,et al. USP Responses to Comments on Stimuli Article, "Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing" , 2008 .

[3] Erika S. Stippler,et al. The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance , 2008, Pharmaceutical Research.