Basic principles of non-clinical development

The terms ‘non-clinical’ and ‘pre-clinical’ are often both used to describe the same type of studies. However, EUPATI has decided to only use the term ‘non-clinical’ in all its course materials because this term is seen as more inclusive.

Non-clinical studies can be carried out at any time during a product’s life (product life cycle). However, they should be done as early as possible in order to avoid surprises later on in the development of the new medicine.

Non-clinical studies can be designed to:

• Identify a medicine’s ‘pharmacodynamics’ (what a medicine does to the body).
• Identify a medicine’s ‘pharmacokinetics’ (what the body does to the medicine).
• Determine a medicine’s ‘toxicology’ (how poisonous or toxic the drug is before giving it to humans).
• Determine a medicine’s safety. This can be done by refining, combining and adding information on safety. And it can be done in the non-clinical phase; at the time of product registration or during the product’s life cycle.