Starting Dose Selection in Fih Trials of Non-high-risk Small Molecules
نویسنده
چکیده
However, when factors influencing risk are identified (e.g. related to the mode of action, the nature of the target, and/or the relevance of animal models) the ‘Minimal Anticipated Biological Effect Level’ (MABEL) approach is recommended. The MABEL by definition is deemed to lead to a minimal biological effect in humans. It is calculated by using all in vitro and in vivo information available from pharmacokinetic/pharmacodynamic (PK/ PD) data.
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Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies.
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