[Early clinical trial of antineoplastic agents--recent perspectives of pharmacological analysis in phase I study].
Importance pharmacological analysis has been widely recognized in conducting early clinical trials of antineoplastic agents, especially phase I trials, in recent years. Pharmacokinetic-pharmacodynamic analysis during dose escalation process is one of the extremely important research endpoints in phase I trials. In addition, measurement of protein unbound drug concentration is more informative for understanding pharmacological difference between patients and animals. Achievable plasma drug concentration which would be compared with preclinical results might be useful surrogate marker to decide optimum administration dose for further clinical investigation in conducting phase I trials of non-cytotoxic or molecular targeting drugs.
Division of Oncology and Hematology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa 277-8577, Japan.
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Sasaki
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic; D006801:Humans
D000970:Antineoplastic Agents