Basic principles of non-clinical development
Completion requirements
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2. ‘Non-clinical’ or ‘pre-clinical’ studies?
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.