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Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents

Background The phase I program of anticancer agents usually consists of multiple dose escalation studies to select a safe dose for various administration schedules. We hypothesized that pharmacokinetic and pharmacodynamic (PK–PD) modeling of an initial phase I study (stage 1) can be used for selecti...

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Detalles Bibliográficos
Autores principales: Zandvliet, Anthe S., Karlsson, Mats O., Schellens, Jan H. M., Copalu, William, Beijnen, Jos H., Huitema, Alwin D. R.
Formato: Texto
Lenguaje:English
Publicado: Springer US 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810279/
https://www.ncbi.nlm.nih.gov/pubmed/19198760
http://dx.doi.org/10.1007/s10637-008-9216-2