The approval process typically involves several key stages:
Preclinical Studies: Initial research conducted in laboratories and on animals to assess safety and biological activity. Clinical Trials: Conducted in phases to evaluate the intervention’s safety and efficacy in humans. These phases include:
Phase I: Tests safety and dosage on a small group of healthy volunteers. Phase II: Expands the study to a larger group to assess efficacy and side effects. Phase III: Conducts large-scale testing to confirm efficacy, monitor side effects, and compare with commonly used treatments. Phase IV: Post-marketing surveillance to monitor long-term effects and effectiveness.
