The accreditors of this session require that you periodically check in to verify that you are still attentive.
Please click the button below to indicate that you are.
CLINICAL (AND BEYOND) IN-USE STABILITY STUDIES – CHALLENGES, CONSIDERATIONS AND CASE STUDIES
Antimicrobial effectiveness testing (AET) is used to confirm that preservative included in a formulation or diluent is effective at inhibiting growth of microorganisms, and AET is a requirement for multi-use drug products. This talk summarizes basic concepts of AET and discusses when testing is necessary. A case study is presented that highlights the need to understand AET variability and its relationship to preservative concentration during early development of a multi-dose program.