Sponsors also need to conduct non-clinical work starting with the beginning of Phase 2 through product launch. These involve toxicological studies in up to 2 species that include qualification of final synthetic processes, reproductive toxicity studies, and susceptibility test development. According to experts and drug sponsors, the cost of all such non-clinical work can range from $3.4 to $4.0 million. In the model, we estimate the average cost of non-clinical work at $3.7 million.
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