Develop strategy to address toxicity issues

Benefit: The development of an appropriate strategy to address animal toxicity may allow successful development of molecules that might otherwise be stopped

Develop strategy to address clinical and regulatory concerns       

Benefit: Aggressive attention to clinical and regulatory concerns based on animal toxicity can reduce drug development delays and failures

Review toxicology documents   

Benefit: Complete, well-written regulatory documents can avoid delays in drug development related to multiple interactions with regulatory agencies on a single point

Design GLP studies

Benefit: Optimal study design will expedite toxicity evaluation and reduce the need for repeat studies

Evaluate and interpret toxicity findings  

Benefit: Provides a scientific basis for assessing the relevance of the animal toxicity to potential successful development of a drug

Assessment of special pathology

Benefit: An accurate, detailed characterization of tissue effects enhances decision-making concerning human relevance.

Due diligence reviews for in-licensing     

Benefit: Critical evaluation of available toxicology data reduces the possibility of delayed completion of development or registration