without prior human use, how is a drug determined safe enough for human clinical trials?

Question

without prior human use, how is a drug determined safe enough for human clinical trials?

In: Biology

Answer 1

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.