The topics chosen for this volume were selected because they are
some of the current development or technological issues facing drug
development project teams. They regard the practical considerations
for assessment of selected special development populations. For
example, they include characterization of drug disposition in
pregnant subjects, for measuring arrhythmic potential, for analysis
tumor growth modeling, and for disease progression modeling.
Practical considerations for metabolite safety testing, transporter
assessments, Phase 0 testing, and development and execution of drug
interaction programs reflect current regulatory topics meant to
address enhancement of both safety assessment and early
decision-making during new candidate selection. Important
technologies like whole body autoradiography, digital imaging and
dried blood spot sample collection methods are introduced, as both
have begun to take a more visible role in pharmacokinetic
departments throughout the industry.
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