PKPD Modeling of Biomarkers in Late Phases of Drug Development

The usefulness and validity of PK/PD models for the evaluation of dose-concentration-effect relationships are not limited to well-designed clinical studies with relatively small groups of patients and frequent measurements of concentration and effect. It has also been shown for observational data obtained from large clinical trials with sparse and imbalanced sampling schedules by applying population modeling techniques. Population PK/PD modeling is based primarily on the nonlinear mixed-effects regression models introduced by Sheiner and co-workers and makes possible the characterization of dose-concentration effect relationships in populations rather than individuals, thereby providing the opportunity to identify and account for sources of interindividual PK and PD variability [21,22].

In addition, the increased understanding of drug action derived from bio-marker response and PK/PD-based drug development may lead to a definition of strategies for individualization of drug dosage regimens to ensure optimal therapeutic outcome in subpopulations of patients. The building of a PK/PD database during drug development can provide an essential framework for continued refinement and improvement during postmarketing drug use, allowing one to answer specific questions without the need to perform additional studies.

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Project Management Made Easy

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