Preclinical studies are essential for several reasons: 1. Safety Assessment: They help in identifying potential toxic effects and the safe dosage range of new treatments. 2. Efficacy Evaluation: Researchers can determine whether the treatment is effective in preventing or treating the disease. 3. Mechanism of Action: These studies provide insights into how the treatment works at a molecular and cellular level. 4. Regulatory Approval: Data from preclinical studies are required for regulatory approval to proceed to human trials.