Using Modeling and Simulation to Determine FIH Dose

Allucent’s client requested assistance using modeling and simulation to determine the First-in-Human(FIH) dose for their program. The drug was created to prevent the toxicity of cytotoxic drugs. However, the sponsor felt that the drug could be studied in healthy volunteers in Phase 1, if given carefully and for a short period. Conducting a Phase 1 study in healthy volunteers would greatly accelerate clinical development. That is where Allucent came in — to help determine how much of the drug could be given and for how long while ensuring subject safety.

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