Developed by the FDA, the Biopharmaceutics Classification System (BCS) helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability.
Critical make-or-break Phase III studies are on the horizon to demonstrate safety and efficacy in large numbers of patients. Is your team ready to manufacture larger batch sizes to support this endeavor? Possibly.
With Quick to Clinic, Thermo Fisher Scientific can deliver your oral solid dose product to the Phase I clinic in as little as 14 weeks from API supply, including 1 month stability data. Now you can meet important milestones and ensure patients receive your discovery…. FAST!
Many of today’s drug development candidates have low solubility and bioavailability challenges, which need to be resolved before clinical studies can be performed. Quadrant 2 helps in early formulation development by insilico predictions of formulations via computational modeling.