Choice of designs and doses for early phase trialsZhou, Y. (2004) Choice of designs and doses for early phase trials. Fundamental & Clinical Pharmacology, 18 (3). pp. 373-378. ISSN 0767-3981 Full text not archived in this repository. It is advisable to refer to the publisher's version if you intend to cite from this work. See Guidance on citing. To link to this item DOI: 10.1111/j.1472-8206.2004.00226.x Abstract/SummaryThis paper reviews state-of-art statistical designs for dose-escalation procedures in first-into-man studies. The main focus will be on studies in oncology, as most statistical procedures for phase I trials have been proposed in this context. Extensions to situations such as the observation of bivariate outcomes and healthy volunteer studies are also discussed. The number of dose levels and cohort sizes used in early phase trials are considered. Finally, this paper raises some practical issues for dose-escalation procedures.
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