Rapid Formulation Pivot Preserves GLP Study Timeline

A GLP repeat-dose toxicology study in canines was set for oral gavage, until formulation development showed the test article was too thick to administer reliably or safely. The problem surfaced late in study startup, when protocol amendments, schedule shifts, and delay fees were all in play.

This case study traces how nonclinical and CDMO teams, working at separate sites, arrived at a capsule dosing approach suited to the material's physicochemical properties while keeping GLP compliance and avoiding a study redesign. It also covers the outcomes for timeline, cost, and continuity, and sets an integrated vendor model against a traditional two-vendor path, week by week.

See how the pivot played out.