Dear colleagues,Back to the Top
For a formulation that has 2 or more strengths BA/BE Guidelines
recommend
that it is the highest strength that will be subjected to BA/BE testing.
BA/BE of the lower strengths are waived provided these lower strengths
have
the same raw material source, same manufacturing process and equipments
and
formula of the active and excipients is in proportion to that of the
highest strength. What if the highest strength fails the BA/BE? Is
there
a need to test the lower strengths to confirm the results? May I invite
your comments.
Thanks.
Joy
Back to the Top
Dear Joy
When your higher strenght formulation is failing in BA/BE studies, you
need
to reformulate the same and repeat the study. As far as my knowledge
goes,
you need not to do study with lower strength. And it is not always true
that if your higher strenght formulation is passing in BA/BE, you will
get
biowaiver for lower strength. There should be dose linerity in dosage
range.
Regards
Mitesh
Back to the Top
Hi.,
Waiver for the lower strengths of a particular formualtion is given if
the formula is dose proprotional.
If the BA/BE studies fails for the highest strength, then reformulation
would be required and again if you need waiver for the lower strengths,
that formula has to be dose proportional.
Regards
Vardhini
Back to the Top
Joy,
If the highest strength fails BE against RLD, then you go back to
formulation development.
Sunil Vandse
Able labs
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)