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Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data

AIMS: During phase I study conduct, blinded data are reviewed to predict the safety of increasing the dose level. The aim of the present study was to describe the probability that effects are observed in blinded evaluations of data in a simulated phase I study design. METHODS: An application was cre...

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Detalles Bibliográficos
Autores principales: Hassing, Gerardus J., van Esdonk, Michiel J., van Westen, Gerard J. P., Cohen, Adam F., Burggraaf, Jacobus, Gal, Pim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9805203/
https://www.ncbi.nlm.nih.gov/pubmed/35895751
http://dx.doi.org/10.1111/bcp.15473