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Martin J. Wolfsegger Alexander Bauer Detlew Labes Helmut Schütz Richardus Vonk Benjamin Lang Stephan Lehr Thomas F. Jaki Werner Engl Michael D. Hale 《Pharmaceutical statistics》2021,20(2):272-281
For the clinical development of a new drug, the determination of dose-proportionality is an essential part of the pharmacokinetic evaluations, which may provide early indications of non-linear pharmacokinetics and may help to identify sub-populations with divergent clearances. Prior to making any conclusions regarding dose-proportionality, the goodness-of-fit of the model must be assessed to evaluate the model performance. We propose the use of simulation-based visual predictive checks to improve the validity of dose-proportionality conclusions for complex designs. We provide an illustrative example and include a table to facilitate review by regulatory authorities. 相似文献
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