Data Analysis

Accurate information regarding the maximum drug plasma concentration (Cmax), area under the plasma concentration-time curve (AUC), terminal half-life (tv) of the drug, and the interindividual variability are valuable for future study designs. The methods for calculation of the parameters are discussed in the section "Data Analysis" on page 199 of this chapter. Although the number of subjects usually is limited in the first human study, initial information regarding dose linearity, i.e., proportional increases in exposure (Cmax and/or AUC) with increasing doses, can be made. An attempt to evaluate information regarding relationships between plasma concentrations of drug and pharmacological effects, surrogate markers, or adverse events is also valuable. Any information regarding such relationships would enhance appropriate future study designs.

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