Ensuring the safety and efficacy of a new drug involves several strategies:
- Thorough Preclinical Testing: Extensive laboratory and animal studies to predict human responses. - Robust Clinical Trials: Well-designed and adequately powered clinical trials to assess efficacy and monitor adverse effects. - Post-Marketing Surveillance: Continuous monitoring of the drug’s performance in the real world through pharmacovigilance systems. - Risk Management Plans: Developing plans to identify, assess, and mitigate potential risks associated with the drug.
