[Pharmacokinetically guided dose-escalation (PGDE) strategy].
When a phase I clinical trial is conducted, the dose escalation strategy is most critical. According to the results of preclinical trials, a rapid and safe dose escalation is necessary. In this regard, a pharmacokinetically guided dose-escalation (PGDE) strategy has been developed. An accelerated dose escalation is conducted by PGDE until reaching 40% target AUC. To determine the MTD of target anti-cancer agents, PGDE appears to be useful.
Saeki
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Dept. of Hematology and Oncology, National Cancer Center Hospital East.
D000818:Animals; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D002940:Circadian Rhythm; D017321:Clinical Trials, Phase I as Topic; D004305:Dose-Response Relationship, Drug; D006801:Humans; D051379:Mice; D009369:Neoplasms / Q000188:drug therapy / Q000378:metabolism*; D013045:Species Specificity
D000970:Antineoplastic Agents