Impurities in drugs: a toxicological approach is needed
In the last years, an increasing concern arose in relation with the potential presence of unexpected impurities in drug products. Such potential presence may induce unwanted and adverse effects in the final patients who take the medicine in order to have therapeutic effects other than unknown adverse toxicological effects. This may be particularly worrying for chronic therapeutic treatment where the prolonged exposure to a certain level of impurities may induce additional diseases other than therapeutic benefits.
It follows that in order to study the possible effects of potential impurities it’s necessary to target the following end-points:
- determine the presence of potential impurities by analytical determination;
- evaluate the level of such impurity/ies in the final drug product;
- evaluate the toxicological profile of each impurity;
- assess the risk assessment in relation to the therapeutic regimen and target patient population;
- make a conclusion: risk acceptable or need to reduce by technical means the impurity level in the dru ... ...