During drug development pharmacological research investigating the effects plays a major role. From early in the preclinical stage until long after the drug is marketed, the potential toxicity or undesirable effects should be investigated. In addition to the determination of the direct effect of the potential drug on the functioning of cells, tissues and organisms, it is the understanding of the underlying molecular mechanism of toxicity that is crucial. In addition, the pharmacokinetics and metabolism is of great importance for the occurrence of (tissue specific) is toxicity. After all, it is not only the product itself but often also the metabolites that cause the undesired pharmacological or toxic effects. And with a variation on the statement of Paracelsus: any drug is potentially toxic, but it's pharmacokinetics, and in particular the exposure to the drug and / or its metabolites, along with individual genetic susceptibility that makes the toxicity manifested.
The scope of Pharmaceutical toxicity include:
- predicting toxicity in preclinical research phase;
- the understanding of the molecular mechanisms of toxicity of drugs;
- extrapolating non-clinical safety studies of risks to humans and animals;
- registration and quantification of toxicity and undesirable side effects in clinical research phases and post-marketing.