Blog

The Significance of Investigational New Drug (IND) Applications and Clinical Trial Applications (CTAs) in Drug Development Strategy

The development of new pharmaceutical treatments requires a rigorous process to ensure safety and efficacy before reaching patients. A crucial...

Equivalence – Via Non-Inferiority ?

In early phase clinical trials Daprodustat* was administered as a once daily dose to hemodialysis patients. However, because standard clinical...

Equivalence – Bridging Studies

Fremanezumab* bioequivalence bridging studies were required to compare early formulations (vials, prefilled syringes) to marketed formulations (autoinjectors). Of note with...

Equivalence – In Vaccine Response

For RSV vaccines, including ABRYSVO®*, equivalence between different lots of the same product Is shown via the "a 1.5-fold criterion"....