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Choice of Starting Dose for Biopharmaceuticals in First-in-Human Phase I Cancer Clinical Trials

Aaron R Hansen1, Natalie Cook1, M Stacey Ricci1

  • 1Drug Development Program, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Division of Hematology and Oncology Toxicology, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA; Department of Medical Oncology, Institut Curie, Paris and Saint-Cloud, France; INSERM U900, Institut Curie, Paris, France; Translational Sciences, MedImmune LLC, Gaithersburg, Maryland, USA.

The Oncologist
|May 13, 2015
PubMed
Abstract

Keywords:
Animal toxicology studiesBiotechnology derived productsHighest nonseverely toxic dosePhase I clinical trialsStarting dose

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