Nonclinical Toxicology Strategy

Nonclinical toxicology strategy supports the evaluation of potential safety risks prior to and during clinical development. Toxicology programs are designed to characterize dose-related effects, identify target organs of toxicity, and inform safe starting doses for human studies.

Effective toxicology strategy aligns study design with regulatory expectations while avoiding unnecessary or redundant testing. Early planning is essential to support IND-enabling activities and ongoing clinical development.

Well-structured toxicology programs provide critical data to support regulatory decision-making and risk assessment.

Nonclinical toxicology activities commonly include:

• Toxicology strategy and study planning

• IND-enabling toxicology program support

• Interpretation of toxicology findings

• Dose selection and safety margin assessment

• Alignment with clinical development plans