THE IMPACT OF PHARMACOKINETICALLY GUIDED DOSE ESCALATION STRATEGIES IN PHASE-I CLINICAL-TRIALS - CRITICAL-EVALUATION AND RECOMMENDATIONS FOR FUTURE STUDIES

被引：40

作者：

GRAHAM, MA

WORKMAN, P

机构：

[1] CRC Department Medical Oncology, University of Glasgow, CRC Beatson Laboratories, Bearsden, Glasgow

来源：

ANNALS OF ONCOLOGY | 1992年 / 3卷 / 05期

关键词：

PHARMACOKINETIC STRATEGIES; PHASE-I TRIALS; DOSE ESCALATION;

D O I：

10.1093/oxfordjournals.annonc.a058203

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Phase I studies requiring multiple dose escalation steps have led to the development of pharmacokinetically guided dose escalation (PGDE) strategies to expedite the conduct of early clinical trials. This article critically reviews PGDE strategies for a number of new anticancer agents including amphethinile, brequinar sodium, iodo-doxorubicin, the anthrapyrazoles (DuP 941, DuP 942 and DuP 937), rhizoxin, and aphidicolin glycinate. The benefits and problems associated with PGDE are examined. Recommendations are made for the optimal deployment of pharmacological information in future phase I studies.

引用

页码：339 / 347

页数：9