The long path to a medicine

5. Animal-free alternative methods have priority

If a substance has successfully passed all the tests, it is approved by the authorities– following a detailed review of the test results – for use in patients. After the market launch, experience with the medicine is systematically recorded and analysed. Further clinical trials yield information about very rare side effects (Phase IV trials). Animal studies may become necessary in this phase as well if a product is to be approved for further diseases (indications) or in a different dosage form and new clinical Phase II or Phase III studies are required. In this case, the principle that animal experiments are only carried out if they are absolutely essential and no alternative methods are available applies throughout the entire cycle of drug development. Every animal experiment requires approval, and everyone who works with animals is required to undergo continuing education.