Translational Challenges From Nonclinical to Clinical Program: Case Study Examples
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D Dandekar, DB Hawver, DB Rao…
International Journal …, 2026
journals.sagepub.com
Drug discovery and development is a complex, lengthy, and expensive process that takes on average 10-15 years and approximately $1-2 billion USD for approval of a new drug. While the studies needed to support clinical development are generally outlined in guidance documents, there is much less guidance on how to translate the nonclinical data into clinical designs. Nonclinical studies are performed to conduct the First-in-Human clinical trial, which is the first major milestone to advance new promising drug candidates, and are conducted …
