In traditional drug development, the efficacy / safety evaluation with respect to dose and the pharmacokinetic and pharmacodynamic evaluation are carried out independently and usually by different people. For substances, in which the efficacy/safety are directly link to the pharmacodynamic and therefore the pharmacokinetics of the substance, combining these evaluations might lead to considerable gain in knowledge. This knowledge might be extremely useful for the dose schedule selection for achieving the required efficacy. An example in a phase II trial in which 153 seasonal allergic rhintis patients were treated with an i.v. application of an anti-IgE compound will be use to illustrate the evaluation of efficacy with respect to pharmaco-dynamic and pharmacokinetics. This information will be use for dose schedule recommendation of the phase III study using a SC route of administration. Population modeling approach will be used, issues concerning parametrization, model and covariate selection will be discussed.

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