作者: Michel Adamina , Markus Joerger
DOI: 10.1517/17425255.2011.543674
关键词:
摘要: Introduction: The first human exposure to a new medicine always carries major risk. Assessment of the safety profile and determination therapeutic dose are formidable tasks, particularly in oncology where toxicity is seen as surrogate for efficacy. Increasing evidence supports adoption innovative dose-toxicity models, these safer more efficient meeting challenges modern investigational than traditional models used Phase I clinical trials. Areas covered: A literature review on was carried out. objective this study provide non-mathematical, reader-friendly overview current with an emphasis recent advances, including benefits Bayesian framework. Expert opinion: Innovative attempt minimize risk maximize research performance. Of these, Continual Reassessment Method Escalation With Overd...