Developing new medicinesSpec 5.20
Developing a new medicine, including a new antibiotic, takes many stages. Each stage checks that the medicine is safe and that it works.
- Discovery: finding a chemical that might treat the disease. These may come from natural sources, such as plants or microorganisms, or be designed in a laboratory.
- Development: the chemical is studied and improved, and a way to make it as a medicine is worked out.
- Preclinical testing: the medicine is tested in the laboratory on cells and tissues, and then on live animals, to find out if it is toxic and whether it works.
- Clinical testing: the medicine is tested on people. It is first given to a small number of healthy volunteers to check it is safe, then to patients to check that it works and to find the right dose.
Only a medicine that passes all the stages can be used to treat patients. The testing protects people from harmful or ineffective medicines.