Scientific leadership across all major nonclinical disciplines required for global submissions.
Toxicology
- General toxicology (acute to chronic)
- Repeat-dose studies
- Local tolerance
- Species/route selection
- Margin assessment and NOAEL justification
Safety Pharmacology
- Cardiovascular, CNS, and respiratory systems
- Integration with PK/TK and tox data
- Regulatory-focused interpretation
Pharmacology & ADME
- Mechanistic pharmacology
- Biodistribution
- Metabolism and excretion
- Exposure justification
DART & Juvenile Toxicology
- Study design and species justification
- Sensitive developmental timing
- Regulatory expectation mapping (ICH S5, S11)
Abuse Liability
- CNS pharmacology and receptor-mediated activity profiling
- Regulatory decision pathways for abuse potential assessment
- Scheduling justification and abuse-related safety evaluation
