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Special Population Studies In Clinical Development: Pharmacokinetic Considerations

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Applications of Pharmacokinetic Principles in Drug Development

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Abstract

Although the primary thrust of research during clinical development of a new molecular entity is to identify a dosing algorithm for the general patient population, the actual patient population in which the drug will be prescribed after marketing approval is far from homogeneous. The fields of pharmacology, pathology, and pharmacogenetics have made it increasingly clear that within the general patient population there exist sub-populations in which drug disposition as well as drug-receptor expression and activity differ from the population average. Depending on the magnitude of these differences and the width of the therapeutic window between effective and toxic blood concentrations, specific subpopulations might require a dose regimen which diverges from the population average regimen. Unmasking and exploring these special populations during clinical development is one of the focuses of clinical pharmacology.

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  1. Clinical Pharmacology Novartis Pharmaceuticals, Basel, Switzerland

    John M. Kovarik

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  1. Aventis Pharmaceuticals, Inc., Bridgewater, New Jersey, USA

    Rajesh Krishna Ph.D., F.C.P.

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Kovarik, J.M. (2004). Special Population Studies In Clinical Development: Pharmacokinetic Considerations. In: Krishna, R. (eds) Applications of Pharmacokinetic Principles in Drug Development. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-9216-1_9

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