Bioequivalence and Bioavailability Forum

Dear Dr. Helmut

Kindly advise me how to conduct BE for a sustained release formulation in UK/EU. Both the innovator and test products are sustained release formulation of same strength. Whether the studies have to be conducted in s.s.a designs. Whether Both fasting and fed BE has to be conducted. Whether BW can be applied based on the highest dose strength if IVIVC performed. If IVIVC has to be performed on what method. is it by Wagner or Loo - Reigelmann method (but no oral solution data is available) or numerical deconvulation method to be used. Kindly clarify

Sincerly,

D.Ahmed