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 <711> 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.
ASJC Scopus subject areas
- Pharmaceutical Science