How formulation properties, absorption, physiology, pathophysiology interfere with systemic exposure
Which study design fits best for BE trials with highly variable drugs
How to optimise adaptive study designs in early- stage trials and in later phases
How pharmacodynamic surrogate parameters are adequately validated
How to select the best clinical endpoint for efficacy trials
How to define patient populations best to allow for both: optimum outcome and effective recruitment
How to find an adequate balance between pragmatism and quality in non-interventional studies and in studies with medical devices
How to validate scores for patient- reported outcome