Drug Development
Research findings from C.H. Takimoto et al update understanding of drug development
Published in Drug Week, April 24th, 2009
" To review the potential impact of Phase 0 trials conducted under the United States Food and Drug Administration (FDA) exploratory IND guidance on oncology drug development. The FDA's exploratory IND guidance document is examined in detail and its practical application to specific Wrst-in-human proof of concept clinical studies called Phase 0 trials is discussed," scientists in the United States report.
" Phase 0 trials represent a novel strategy for accelerating the development of the next generation of anticancer treatments. Phase 0 studies are conducted prior to conventional toxicity-defined dose-escalation studies and these trials do not explore maximum toxicity...
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Source: Drug Week (2009-04-24)
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