Area of interest of the section Pharmaceutical Toxicology
The domain of pharmaceutical toxicology lies in the intersection of toxicology and pharmaceutical science, and includes all research into the harmful effects and safety of medicines in relation to their therapeutic benefits.
During drug development, pharmacological research, including investigating side effects plays a major role. From early in the preclinical phase until the drug is withdrawn from the market, the potential toxicity or undesirable effects are investigated. Apart from establishing the direct effect of the potential medication on the functioning of cells, tissues, organisms and human beings, understanding the underlying molecular mechanism of toxicity is crucial. In addition, pharmacokinetics and metabolism are of great importance for the occurrence of (tissue specific) toxicity.
After all, it is not only the drug itself, but often also the metabolites that may cause the undesired pharmacological or toxic effects. And with a variation on the statement of Paracelsus: any drug is potentially toxic, but it's its pharmacokinetics, and in particular the exposure to the drug and / or its metabolites, along with individual genetic susceptibility that determines if the toxicity will manifest itself.
The scope of Pharmaceutical Toxicology includes:
- predicting toxicity in the preclinical research phase;
- understanding the molecular mechanisms of toxicity of drugs, metabolites, excipients and impurities;
- extrapolating data from non-clinical safety research to risks in humans, both adults and children;
- registering and quantifying toxicity and undesirable side effects in the clinical research phases and during the post-marketing phase.