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Is Your DART Study Set Up for Success?
A single mistake during the Developmental and Reproductive Toxicology phase can waste considerable investment dollars, delay launch, or worse -- lead to a drug or vaccine that goes to market with DART effects missed in the study. These questions can help mitigate the risk of missteps in your DART study.
Are you using tox generalists to perform DART analysis?
DART studies require researchers with the specialized experience to evaluate subtle changes and make subjective interpretations.
Are your DART researchers asking the right questions?
Seasoned DART investigators use their knowledge of FDA requirements, drug development plan, and preclinical data for effective study design.
Does your team have enough control data to define "normal?"
DART professionals use relevant historical control data to identify which abnormalities truly fall outside the normal range for each species.
Can your team properly defend and document research analysis?
Study results properly documented and interpreted by a DART researcher may have a higher likelihood of FDA acceptance.
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