Learning-confirming cycles

Pharmaceutical drug development has traditionally been performed in sequential phases, preclinical as well as clinical Phases I to III, in order to answer the two basic questions - which compound should be selected for development, and how it should be dosed. This information-gathering process has recently been characterized as two successive learning-confirming cycles (Fig. 1.4) [8, 9]. The first cycle (traditional Phases I and Ha) comprises learning - in healthy subjects -what dose is tolerated and confirming that this dose has some measurable bene-... 

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