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- W2065093669 endingPage "281" @default.
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- W2065093669 abstract "Quantitative estimations of first-in-human (FIH) doses are critical for phase I clinical trials in drug development. Human pharmacokinetic (PK) prediction methods have been developed to project the human clearance (CL) and bioavailability with reasonable accuracy, which facilitates estimation of a safe yet efficacious FIH dose. However, the FIH dose estimation is still very challenging and complex. The aim of this article is to review the common approaches for FIH dose estimation with an emphasis on PK-guided estimation. We discuss 5 methods for FIH dose estimation, 17 approaches for the prediction of human CL, 6 methods for the prediction of bioavailability, and 3 tools for the prediction of PK profiles. This review may serve as a practical protocol for PK- or pharmacokinetic/pharmacodynamic-guided estimation of the FIH dose." @default.
- W2065093669 created "2016-06-24" @default.
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- W2065093669 creator A5069778809 @default.
- W2065093669 creator A5082668112 @default.
- W2065093669 creator A5087527525 @default.
- W2065093669 date "2012-03-10" @default.
- W2065093669 modified "2023-09-27" @default.
- W2065093669 title "Applications of Human Pharmacokinetic Prediction in First-in-Human Dose Estimation" @default.
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