- April 1, 2025The development of new pharmaceutical treatments requires a rigorous process to ensure safety and efficacy before reaching patients. A crucial…
- January 10, 2025In early phase clinical trials Daprodustat* was administered as a once daily dose to hemodialysis patients. However, because standard clinical…
- January 10, 2025Fremanezumab* bioequivalence bridging studies were required to compare early formulations (vials, prefilled syringes) to marketed formulations (autoinjectors). Of note with…
- January 10, 2025For RSV vaccines, including ABRYSVO®*, equivalence between different lots of the same product Is shown via the "a 1.5-fold criterion".…
