Therapeutic candidates undergo a rigorous evaluation process that includes:
1. Preclinical Studies: Initial testing in cell cultures and animal models to evaluate efficacy and toxicity. 2. Clinical Trials: Multi-phase trials in humans to assess safety, efficacy, dosage, and side effects. - Phase I: Focuses on safety and dosage. - Phase II: Evaluates efficacy and side effects. - Phase III: Confirms efficacy and monitors adverse reactions in large patient groups. - Phase IV: Post-marketing studies to gather additional information on risks, benefits, and optimal use.
