Preclinical Testing Before a drug is tested in humans, it undergoes preclinical testing in the laboratory. This includes testing on animal models to evaluate the drug's safety and biological activity. Preclinical data must show that the drug is reasonably safe before it can proceed to clinical trials.
Clinical Trials Clinical trials are conducted in several phases:
Phase I: Involves a small group of healthy volunteers to assess the drug's safety, dosage range, and side effects. Phase II: Focuses on a larger group of patients with the target condition to evaluate the drug's efficacy and further assess its safety. Phase III: Involves an even larger group of patients to confirm efficacy, monitor side effects, and compare the drug to commonly used treatments. Phase IV: Post-marketing studies conducted after the drug has been approved, to gather additional information on the drug's risks, benefits, and optimal use.
