Characterizing the dose response relationship and subsequent determination of an adequate dose level in humans are key objectives in the development of a medicinal product. Dose finding studies and modeling and simulation techniques play a key role in the transition of a drug from the non-clinical to the clinical phase and represent the gatekeeper for first in human studies and large confirmatory clinical trials.
With the rise of precision medicine comes a promise for greater dose ﬂexibility to further improve efﬁcacy and reduce adverse effects. Some groups in the population require special clinical studies due to specific dosing, pharmacokinetics and administration characteristics. The use of medicines in the elderly requires special consideration due to the frequent occurrence of underlying diseases and the consequent risk of medicines interaction of the various treatment regimens. Gender and sex are important drivers of phenotypic variability in patient populations. Microdosing studies offer the possibility to study the mechanism of action and pharmacodynamics with sub-therapeutic exposure.
The seminar is designed to provide an overview of current concepts in non-clinical and clinical pharmacology and drug dosing with special consideration of the individual patient and the predisposition of special populations.
We look forward to welcoming you and your colleagues on 10 February, 2022!
Spitalstrasse 41, Basel, Switzerland