Preclinical Testing in the Development of Probiotics: A Regulatory Perspective withBacillusStrains as an Example

Abstract excerpt

Preclinical testing of the microbial strains is the first important step in the development of probiotics. Requirements for the set of tests can vary depending on the bacterial species and the expected mechanism of action in the organism. Common approaches to preclinical testing of probiotic strains include strain identification (i.e., determination of phenotypic and genotypic properties), safety evaluation...

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