CNS Drug Development
Our team of highly experienced drug developers can help you design the right strategy and activities.
CNS Drug Development
Our team of highly experienced drug developers can help you design the right strategy
and activities.
> Integrated development plan
> Clinical and clinical pharmacology plans
> Gap analysis for regulatory and development programs
> Suitable clinical and clinical pharmacology study designs
> Translational plans from Candidate selection to Phase 2 testing
> Key endpoints and biomarkers to demonstrate clinical proof of concepts
> Demonstrating CNS drugs achieve relevant brain exposure
> Demonstrating target engagement and target occupancy
> Defining human equivalent doses from preclinical model
> Modelling and simulation
> Defining risks and Mitigation plans
> DMPK and Clinical Pharmacology support at all stages of development
> Non-clinical safety and toxicology requirements and study interpretation
> Integrated Due Diligence
- Integrated development plan
- Clinical and clinical pharmacology plans
- Gap analysis for regulatory and development programs
- Suitable clinical and clinical pharmacology study designs
- Translational plans from Candidate selection to Phase 2 testing
- Key endpoints and biomarkers to demonstrate clinical proof of concepts
- Demonstrating CNS drugs achieve relevant brain exposure
- Demonstrating target engagement and target occupancy
- Defining human equivalent doses from preclinical model
- Modelling and simulation
- Defining risks and Mitigation plans
- DMPK and Clinical Pharmacology support at all stages of development
- Non-clinical safety and toxicology requirements and study interpretation
- Integrated Due Diligence
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