Solve API Preparation Problems, Supply API, And Support GLP Toxicology For IND

By Ricerca Biosciences

Client initiated a 28-day toxicity study in dogs, which was on critical path to IND filing date. The test compound prepared outside of Ricerca could not be properly formulated and the quantity was less than needed for the dog study.

To meet the IND filing deadline, the client asked Ricerca to characterize the existing API and identify the cause of the formulation problems, to reprocess the lot, if necessary, and to prepare additional material to ensure the study could be completed.