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- W2364866401 abstract "Aim To introduce a new pharmacodynamic and pharmacokinetic intergrated approach that determines starting dose for firstin-human trials.Methods The four basic steps were characterization exposure-response relationships observed in animal experiments,correction for interspecies difference and prediction of human exposure-response relationships,diagnosing and predicting pharmacokinetic properties of the drug in human,prediction of human dose-responses and dose selection for first-in-human trials.Results The approach predicted that the dose for a drug was similar to MRSD approach recommended by FDA.Conclusion The new approach can be used to determine starting dose for first-in-human trials." @default.
- W2364866401 created "2016-06-24" @default.
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- W2364866401 date "2012-01-01" @default.
- W2364866401 modified "2023-09-25" @default.
- W2364866401 title "Starting dose determination approach for first-in-human trials" @default.
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