Academic Pharma

Non-clinical development

After discovery, a candidate medicinal product is further developed in non-clinical studies. These include in vitro (cell, organoids, organ on a chip) and in vivo (animal) experiments.

A large part of non-clinical studies focus on safety. You must demonstrate the candidate medicinal product is safe for pharmacokinetics and toxicokinetics, as well as (safety) pharmacology and toxicology, including general toxicity, reproduction toxicity, genotoxicity, carcinogenicity, immunotoxicity and photo safety. Dose finding, drug delivery, drug-drug interaction and efficacy studies are also part of the non-clinical development studies. Which non-clinical studies should be performed depends on the candidate medicinal product.

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A large part of non-clinical studies focus on safety. You must demonstrate the candidate medicinal product is safe for pharmacokinetics and toxicokinetics, as well as (safety) pharmacology and toxicology, including general toxicity, reproduction toxicity, genotoxicity, carcinogenicity, immunotoxicity and photo safety. Dose finding, drug delivery, drug-drug interaction and efficacy studies are also part of the non-clinical development studies. Which non-clinical studies should be performed depends on the candidate medicinal product.

Most studies should be performed before the initiation of clinical trials. However, non-clinical development continues during the clinical development stage. Therefore, it is useful to design a development plan before starting any study.

The LUMC has a large research community that can assist with non-clinical studies. If it is not possible to perform the study at the LUMC, we have a network of reliable partners able to help further.

Projects

Contact

If you are interested in designing or conducting non-clinical studies, we can think along with your development plan and bring you into contact with other researchers at the LUMC.