Of mice and then men
Drug development typically follows a path from theory and concept, to drug/chemical/biological production, to test tube testing for in vitro efficacy, to animal testing to early phase I first in human testing.
A crucial step in understanding the behaviour of a drug and safety analysis before proceeding to humans is testing a drug in animals.
A number of animals are used for in vivo testing including mice, rats, rabbits, dogs and monkeys.
Animals can be healthy or manipulated to provide an animal-model for the disease/medical condition being tested.
Animal testing aims at obtaining important information about
- General and specific toxicicity
- Highest safety/tolerated doses
Animal testing must be conducted in an ethical manner, in line with good clinical practice guidelines and in a facility that can obtain high quality data.
The results of the animal testing are crucial in determining the safety of the drug to move into human studies.
The information obtained will lead to a human starting dose, awareness of possible side effects to monitor for (such as ECG changes requiring cardiac telemetry), awareness of possible metabolites and possible toxicities (such as liver inflammation).