It should start with preclinical experiments on ethical animals before moving on to clinical trials. After clearing these studies and receiving regulatory approval, proceed to clinical trials.
Clinical studies are likewise separated into four stages.
1. Phase 1—in this scenario, only healthy volunteers will be kept, and the number will be limited to 30 to 90 persons. Its major goal is the subject’s safety, and the subject is identified as a volunteer.
2. Phase 2—– Following successful completion of the phase 1 trial or clearance from the regulator for phase 2 testing. In this situation, we chose 100 to 500 healthy volunteers and individuals suffering from the same or a comparable condition. This is the primary goal for the drug’s effectiveness.
3. Phase 3- Phase 3 is similar to Phase 2, except that we take 1000 to 5000 healthy volunteers and subjects suffering from the same or a comparable ailment. Its primary goal is safety and effectiveness.
4. Phase 4 – Following approval from the regulator, phase 4 will begin, with 1000 to 5000 participants participating. Its primary goal is to assess medication risk, benefit, pricing, and market strategy.