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pubmed-article:11595684pubmed:abstractTextIn the setting of target-based anticancer drug development, it is critical to establish that the observed preclinical activity can be attributed to modulation of the intended target in early phase trials in human subjects. This paradigm of target modulation allows us to determine a Phase II or III dose (optimal biochemical/biological modulatory dose) that may not necessarily be the maximum tolerated dose. A major obstacle to target-based (often cytostatic) drug development has been obtaining relevant tumor tissue during clinical trials of these novel agents for laboratory analysis of the putative marker of drug effect.lld:pubmed
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pubmed-article:11595684pubmed:articleTitleSequential tumor biopsies in early phase clinical trials of anticancer agents for pharmacodynamic evaluation.lld:pubmed
pubmed-article:11595684pubmed:affiliationDivision of Hematology/Oncology, Department of Medicine, Ireland Cancer Center at University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA. axd44@po.cwru.edulld:pubmed
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