Anyone know what is meant by phase 2 trial of a drug?

Question

What happens in a phase 2 trial????

Answer 1

I believe that it meand upgrading from ape to human trials but i'm not sure.

Answer 2

I know pharmaceutical companies study different parameters in different phases. For instance, a phase 1 might be safety (side effects) and the cohort is relatively small and a phase 2 might be efficacy and long-term safety with a larger group, while a phase 3 might be superiority over other drugs and an even larger group. There are probably more detailed guidelines for determining what might constitute a phase but what I just wrote was a general guideline.

Answer 3

Once the initial safety of the therapy has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess clinical efficacy of the therapy; as well as to continue Phase I assessments in a larger group of volunteers and patients. The development process for a new drug commonly fails during Phase II trials due to the discovery of poor efficacy or toxic effects.

Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements, whereas Phase IIB is specifically designed to study efficacy.

Some trials combine Phase I and Phase II into a single trial, monitoring both efficacy and toxicity.

Answer 4

Phase two is when you start testing your drugs on people with the specific illness you intend to treat. Well, that is phase 2 clinical trials at least.
Phase 1 clinical is where you test it on college students to see what the side effects are. That;s where they get their lists of side-effects on commercials.

Answer 5

It means its more addictive and more sedative.

Answer 6

may be death.