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A Survey of the Way Pharmacokinetics are Reported in Published Phase I Clinical Trials, with an Emphasis on Oncology
Clinical Pharmacokinetics, 08/10/09
Comets E et al. – In this review, authors found that this information was often either missing or incomplete, which hinders that objective. The authors suggest several improvements in the design and the reporting of the methods and results of these studies, to ensure that all relevant information has been included. Pharmacokinetic findings should also be integrated into the broader perspective of drug development, through the study of their relationship with toxicity and/or efficacy, even in the early phase I stages.
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