The Next Humans

All the important data from the first patient should be available in 48 h. Consider the toxicokinetic data in several species. At what blood concentrations have the animals begun to manifest effects? What were the concentrations in the first human? Considering the acute toxicity in animals, should you next give a dose to the second human that will achieve one-third or two-thirds the minimal effective plasma water concentration in animals? Give the second patient labeled material and complete the studies in 48 hours. From the first patient you have begun to recognize which samples are the most important to analyze immediately. As you approach the minimally effective dose, institute efficacy and surrogate efficacy assessments.

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