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)
2 Dysregulation of gut microbiota in patients with immune thrombocytopenia The organ with the largest distribution of microorganisms in the human body is the intestine, and the composition of the intestinal microbiota is complex and diverse, including bacteria, fungi, viruses, and protozoa, among which bacteria dominate, with a mass of about 0.2 kg (Sender et al., 2016
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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
