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Drug Project Toxicology
Discovery Phase:
Early consideration of potential safety liabilities from the drug target of lead molecules should form part of every discovery project. We will work with you to develop a balanced view of potential safety risks, directing you towards higher quality lead molecules and a greater chance of long term success.
Working alongside your team we will:
- Design and deliver a bespoke experimental strategy to address potential safety concerns
- Conduct focused target safety assessments to provide a succinct, risk-focused report that is directly aligned to your needs.
- Explore potential in vitro and in vivo models that may enhance understanding of toxicities and their translation into the clinic.
Development Phase:
The regulatory GLP studies that underpin the clinical programme should be individually designed to address the scientific questions posed by the molecule, the indication and intended clinical use. Working in partnership with you, we will build a tailored, cost-effective non-clinical safety programme that enables the rapid execution of your clinical and regulatory development strategies.
Working seamlessly with your project team we will:
- Develop a nonclinical safety strategy that enables your clinical objectives
- Independently select the right CRO, develop study designs, manage study delivery, interpret data and review reports
- Prepare the nonclinical sections of regulatory submission documents including, IMPD, IB, CTA, NDA/MAA/JNDA, expert reports
- Provide nonclinical support for regulatory agency meetings throughout the world, including China and emerging markets.
