作者: Patrick V. Acevedo , Deborah L. Toppmeyer , Eric H. Rubin
DOI: 10.1007/978-1-59259-739-0_17
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摘要: Phase I trials play a pivotal role in the introduction of new anticancer drugs into clinic, and there are important ethical differences between phase oncology involving normal volunteers. In addition, recent advances cancer biology have resulted many drug targets led to approaches trial design. Although may involve Food Drug Administration (FDA)-approved (used schedules or combinations), this chapter reviews objectives, design, methodology, ethics for single investigational compound.