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I am developing one of the sustained release generic formulation which
is available in two differrent strengths. The higher strength is the
RLD strength in the US. Hence we are planning for a fasted and a fed
study with the RLD strength.
However, the lower strength we developed is not dose proportional to
the higher strength. Also qualitatively it differs in one of the
non-release controlling excipient. Hence we wish to plan a BE study
with the lower strength as well; since the lower strength does not meet
the waiver requirements.
Now, we have a query so as to what could be the reference product used
for the BE study on lower strength of ours. Is it necessary that this
be the equivalent strength of the innovator or can we use any of the
generic formulation in the market as our reference?
Also, shall we require to do both the fasted as well as the fed study
with the lower strength as well?
wil be grateful to have some of your views on the above.
thanx and regards,
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[I've been out of two for a few days without convenient email access -
I'm back - db]
The following message was posted to: PharmPK
I think you are right in deciding for doing bio of lower strength also.
As far as taking reference product for such a study is concerned I
believe you should do it for 2 tablets (at once) of lower strengths vs.
one single tablet of RLD. But this kind of study design may put you at
risk as gastric emptying of 2 tablets may differ from that of gastric
emptying of single tablet.
Regarding the requirement of Fed study, if the food effect is mentioned
you will be required to do it.
I think if we receive some comments from some body from Regulatory
agency, it would be better and if you get any such response in future,
I would be delighted if you decide to share the same with all.
Manoj K. Paruthi
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