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Antimicrobial Effectiveness Testing: A Case Study in Finding the Right Balance
Date
September 9, 2020
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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.
Speaker
Pfizer, Inc.
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