24.04.2024

Information for industry - reference and standardised AST.

EUCAST guidance on how to determine MIC values and develop distributions (and zone diameter distributions) for new agents in preparation for EUCAST and EMA evaluation.

The development of new agents requires agreement and acceptance of the data generated in support of decisions on clinical breakpoints, wild type MIC distributions, ECOFFs and routine susceptibility testing correlates. EUCAST and CLSI both favour the use of the non-modified ISO recommended reference broth microdilution for this purpose, and only occasionally is there good reason to deviate from this. When this is considered necessary it is strongly adviced that it is with the agreement and full understanding of standards committees and agencies, such as CLSI, EUCAST, FDA and EMA.