Bioequivalence and Bioavailability Forum

❝ Can anyone explain me the procedure for selection of reference formulation

❝ to be used for bioequivalence study for european submission studies? (Like

❝ Orange book listed RLD is used for USFDA market)

• There's nothing like the orange book in the EU.
  
• The innovator's formulation with a current MA (market authorisation) in any of the 27 member states of the European Union (and associated countries of the European Economic Area EEA: Norway, Iceland, Liechtenstein; see here) can be used.
  
• Now it's up to you to select an appropriate reference batch. Most people do that based on dissolution and potency. For details see Section 4.1.2 of the BE-GL.