Format:
x, 141 Seiten
,
Diagramme, Illustrationen
Content:
During the drug discovery & development process, several phases encompassing a number of preclinical and clinical studies have to be successfully passed to demonstrate safety and efficacy of a new drug candidate. As part of these studies, the characterization of the drug's pharmacokinetics (PK) is an important aspect, since the PK is assumed to strongly impact safety and efficacy. To this end, drug concentrations are measured repeatedly over time in a study population. The objectives of such studies are to describe the typical PK time-course and the associated variability between subjects. Furthermore, underlying sources significantly contributing to this variability, e.g. the use of comedication, should be identified. The most commonly used statistical framework to analyse repeated measurement data is the nonlinear mixed effect (NLME) approach. At the same time, ample knowledge about the drug's properties already exists and has been accumulating during the discovery & development process: Before any drug is tested in humans, detailed …
Note:
Dissertation Universität Potsdam 2017
Additional Edition:
Erscheint auch als Online-Ausgabe Solms, Alexander Integrating nonlinear mixed effects and physiologically–based modeling approaches for the analysis of repeated measurement studies Potsdam, 2017
Language:
English
Keywords:
Hochschulschrift
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