without prior human use, how is a drug determined safe enough for human clinical trials?
In: Biology
Drugs first go through animal testing before being tested on humans. After that testing is completed successfully, phase I human trials start and are limited to usually 20-100 people and are meant to test for safety and dosage. If phase I is successful, the drug moves on to phases II and III which test for efficacy/side-effects and efficacy/adverse reactions.
There’s also a lot of science going into the development of the drug before animal trials that adds to the calculus of it all.
By testing on animals, normally. Most mammals have sufficiently similar biology that it will catch the worst drug interactions, so you can be pretty sure it won’t kill them, and it’s safe enough to give to willing volunteers who know its an experimental drug.
They tend to favour mice and rats for these tests, hence “lab rat” as an expression, and the premise of “Pinky and The Brain”
Usually animal testing. Even with a drug that hasn’t been tested on humans, scientists have a pretty good idea of the effects and potential toxicity. Animal testing can weed out major, obvious issues.
Human clinical trials start with a Phase 1 trial, which is only on a limited number of volunteers (100 or so). If Phase 1 trials are successful, then broader trials can commence.
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