The European Medicines Agency's (EMA) productâ€specific bioequivalence indicates the outline harmonised regulatory desires for studies to demonstrate bioequivalence for merchandise that may have specific desires owing to their material medical, additionally to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision making.
- Track 1-1 Generics
- Track 2-2 Biowaiver
- Track 3-3 In Vitro dissolution