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Bioanalysis is the discipline that allows the quantitative determination of chemical entities and biomarkers in biological matrices. Analytical methods must generate reproducible and reliable data to allow valid interpretation of the studies for which they support. This science bridges the gap between the administration of a drug during preclinical or clinical trials and the interpretation of the analytical data for pharmacokinetic or pharmacodynamic purposes.
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Quantitative Clinical Development (QCD) combines clinical pharmacology modeling and simulation with clinical PK/PD and…
Data Driven Insights
First in Human Studies
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Study Design, Start-up and Execution