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Overall success rate of a safe and efficacious drug: Results using six phase 1 designs, each followed by standard phase 2 and 3 designs

To evaluate the overall success rate of a new drug, phase 1, 2, and 3 trials were simulated using eight toxicity and two non-decreasing efficacy profiles. Six phase 1 designs including the standard 3 + 3, CCD, BOIN, mTPI, mTPI-2, and CRM were considered with standard phase 2 and 3 designs. Based on...

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Detalles Bibliográficos
Autores principales: Ruppert, Amy S., Shoben, Abigail B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139598/
https://www.ncbi.nlm.nih.gov/pubmed/30225393
http://dx.doi.org/10.1016/j.conctc.2018.08.010