Preclinical And Nonclinical Studies—What Is The Difference, And Where In Your Program Should They Fall?

By Camille Delouche, MSc, Commercial Operations Associate

Have you ever wondered about the difference between preclinical and nonclinical studies? While those in scientific fields like pharmaceutical development are accustomed to words with specific agreed-upon definitions to facilitate communication and minimize misunderstandings, these two terms seem to have slipped through the cracks. Their similar meanings often make it difficult to determine which word is appropriate in a given context and which studies fit their definitions across the development landscape.

So when should each term be used, and what are the appropriate timelines for preclinical and nonclinical studies within a drug development program?