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AUC area under the curve, C max maximum concentration, EFD embryo-fetal development, mAb monoclonal antibody, MABEL minimum anticipated biological effect level, NOAEL no adverse effect level.
AUC area under the curve, C max maximum concentration, C plasma plasma concentration, C semen seminal concentration, EFD embryo-fetal development, MABEL minimum anticipated biological effect level, NOAEL no adverse effect level Fig. 2 Safety margin estimations: monoclonal antibodies.
AUC area under the curve, C max maximum concentration, C semen seminal concentration, EFD embryo-fetal development, mAb monoclonal antibody, MABEL minimum anticipated biological effect level, NOAEL no adverse effect level.
ADI acceptable daily intake, AUC area under the curve, C max maximum concentration, EFD embryo-fetal development, MABEL minimum anticipated biological effect level, NOAEL no adverse effect level, PDE permissible daily exposure Fig. 4 Algorithm for monoclonal antibodies.
In the absence of EFD studies, end of relevant systemic exposure may be based on the principles of a Minimum Anticipated Biological Effect Level (MABEL) or other accepted principles.
As MEDI-546 binds to a novel target (IFNAR1) that plays a major role in the IFN pathway, the starting dose of 0.1 mg/kg was recommended based on a translational modeling and simulation approach to predict the minimum anticipated biological effect level in humans.
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A maximum for the false match rate F' can be estimated using an anticipated minimum match rate.
As it transpired, we recruited more patients not receiving immediate antibiotics than the minimum we initially anticipated.
To analyse the main outcome by patient satisfaction, the number of participants required was based on an anticipated minimum 30% response rate to the patient survey, resulting in an estimation of approximately 600 individual patients required.
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