Hi everybody,Back to the Top
I am dealing with one of the sustained release generic formulation for
European submission. I wonder if some of you could guide me in
selection of the types of BE studies required to prove equivalency with
the innovator formulation.
Ours is a beaded capsule formulation with multiple strengths, which are
dose proportional. We are planning to conduct a single dose fasted and
the food effect studies only on the highest strength for our
However, the European Guidelines on modified release dosage forms [ref:
CPMP/EWP/280/96, July 1999] mentions that applications of modified
release dosage forms essentially similar to marketed modified release
forms should demonstrate the steady state performance also [in addition
to the fasted and the fed state single dose studies].
Will it be sufficient if we go for single dose studies only or shall we
have to conduct a steady state study also.
Dear Ashok,Back to the Top
Refer EMEA "Note for Guidance on the investigation of bioavailability
and bioequivalence" 26 July 2001 CPMP/EWP/QWP/1401/98. Page number 5. I
hope you will find your answer.
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (firstname.lastname@example.org)