stands for Investigational New Drug). An IND is only issued after a new drug’s developer has conducted laboratory tests and trials in animals that demonstrate that the agent is not unacceptably toxic. In addition, the manufacturer provides the FDA with its evidence for believing that the treatment is going to be useful in a particular disease or condition.
The evaluation of a new drug in the lab or in animals is known as pre-clinical testing. Ideally, in developing a new drug, scientists try to identify an animal disease that is similar to a particular human illness and first test the drug in animals. One of the complications of AIDS/ARC/HIV infection drug development is that nobody has identified an animal model for the syndrome that provides a reliable testing system, at least not in small animals that would make extensive laboratory-based experimentation possible. As a result, the rationale for experimentation with most drugs being considered for AIDS/ARC has come from “test-tube” type research. Scientists refer to this as in vitro testing, from the Latin meaning “in the glass”; tests in animals or people is called in vivo, meaning “in the living.”
