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The predicted human PK parameters were used to define the escalation steps in this study, while information from nonclinical toxicology studies was used to define the starting dose, following the recommendations of the ICH-S9 Guidance Document

Garcia-Martinez, L., Zhang, Y., Nakata, Y., Chan, H

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Another direction could be the development of humanized animal models such as mice colonized with human microbiota or with humanized immune systems (Ka et al., 2023)

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