Getting the dose right
Curare experts translate nonclinical results into targeted early clinical development programs by including informative biomarkers to guide early decision making and dose selection where possible.
In clinical pharmacology, we are focused on securing the correct dosage as soon as possible in any drug development program. For the overall population, but also for specific target groups such as children.
Key activities, executed at the appropriate moment, mitigate the risks within the development program. A considered analysis of the results justifies the selection of the starting dose and dose escalation steps in a first-in-human study, and an optimal dose regimen in the course of further development. Data from in-house pharmacokinetic and pharmacodynamic analyses can be used to corroborate the path forward, as well as PK/PD modelling.
Results from the clinical pharmacology program (including possible drug-drug interaction and special population studies), ultimately culminate in the respective modules of the submission package and support the prescribing information at the marketing authorization stage.