Development and commercialization of discoveries from these sources often takes place under licensing arrangements with established commercial entities. Animal Testing Promising laboratory discoveries are generally tested on rabbits, rats and other animals to gather data regarding safety and efficacy. The FDA does not usually have direct involvement in these tests, but researchers are usually responsive to FDA guidelines on data that it expects in requests to conduct human clinical trials. Animal studies focus on the rate and amount of the drug s absorption into the blood, the action of the body in response to the drug, the compounds produced as a result of the drug s breakdown, and the speed at which drug breakdown and excretion occur. In response to results from these studies, the drugs are modified to enhance desirable effects.
Most tests involve two or more species, since responses often vary from species to species.
Only a miniscule percentage of drug compounds tested on animals actually continue on to human clinical trials. Negative results often stem from poor drug absorption rates, unacceptable toxicity of the drug or its breakdown compounds, and an absence of efficacy in animals. Sponsors of an IND submit their laboratory and animal studies and proposed plans for human studies. The data and proposals are scrutinized by both the FDA and a local institutional review board. On-going trials are sometimes also reviewed by an independent Data and Safety Monitoring Board.