Targeted clinical investigations
When significant risks are identified from pre-approval clinical trials, further clinical studies might be called in to evaluate the mechanism of action for the adverse reaction. In some instances, pharmacodynamics and pharmacokinetic studies might be conducted to define whether a particular dosing instruction can put patients at an increased risk of adverse events.
Moreover, based on the pharmacological properties and the predictable use of the medicine in general practice, conducting specific studies to scrutinize potential medicine medicine interactions and food-medicine interactions might be entitled to. These studies can comprise population pharmacokinetics studies and medicine concentration
monitoring in patients and normal volunteers.
One drawback of this method is that the outcome measure might be too shortened and this might have an influence on the quality and eventual usefulness of the results of the trial. Large, simplified trials are similarly resource-intensive