There is No Viable Alternative to Animal Studies
[Posted on: Monday, August 27, 2015]

Since the onset of formal safety and efficacy testing of drugs before their market approval almost 60 yr ago, animal studies have formed the backbone of testing before a given experimental drug can be tested in humans. Supported by principles of ethical clinical research and sound scientific basis, regulators framed laws defining the kind of animal testing needed to support the rationale of human testing prior to approval. But in the last 20 years there has been another strong voice, that of animal rights. And extensive research has been done to find out alternatives to animal testing. Since late 1990s, there has been a strong emphasis on computational biology to define better targets and in-silico or ex-vivo testing to avoid or reduce animal testing. A recent survey reviewing research to find alternatives to animal testing between 1980 and 2013, found that despite the best efforts, animal tests are still considered the most reliable information to predict the safety of a given drug product. Advances have been made in reducing unnecessary testing, and improving cell culture experiments to eliminate some animal tests such as genetic toxicity, mechanism of action, and drug-drug interactions, however, regulators still heavily rely on animal experiments to clarify critical safety issues related to a given drug. Several testing models such as in silico protocols and ex vivo testing for eye irritations have shown limited promise, while in vitro tests have increased in prominence. So, if you are developing a new drug, there is still no alternative to animal toxicity studies, but you can certainly reduce unnecessary animal tests by employing more in vitro testing.