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Safety studies

To support you in the planning of a pharmaceutical project, we here describe the different steps in the drug development process.

Please contact us if you have any questions.

Toxicology studies

Irrespective of therapeutic modality, before clinical use is allowed by regulation, safety studies occur throughout the preclinical phase using a variety of in silico, in vitro, and in vivo methods, to varying standards (according to Good Laboratory Practice when required).

In silico

Computer-based predictions of potential hazards and toxicities have now matured to a point where they provide a strong “heads up" in guiding lead series development and subsequent in vitro and in vivo studies.

In vitro

Contemporary lead optimisation generally now involves the use of a battery of cellular models that reveal the potential for eliciting key toxicities, such as hepatotoxicity, kidney toxicity, and cardiotoxicity. Many of these are now utilizable in high throughput format.

In vivo

Toxicological animal studies are performed on relevant animal species, usually first on rodents. Other animal species that occur are dog, pig and monkey. Animal studies should be designed according to 3R principles, ie with high ethics and focus on animal welfare throughout the study. In vivo studies should be carried out in a well-structured and regulated (GLP when required) manner, and carried out in an authorized facility, as they ultimately serve regulatory submission and acceptance of the treatment into clinical studies.