Dissolution testing is an in vitro technique can be used as a substitute for in vivo studies under strictly defined and specified conditions A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent.
Prime Health provides the following to assist in the submission of a biowaiver:
- Study Protocol
- Systematic method development and the validation package for dissolution profile generation
- Study report – F1, F2 computation, graph comparisons between the innovator (reference product) and test product