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The following message was posted to: PharmPK
Hello,
Our Lab will do BE study (pharmacokinetic) for Diazepam Rectal
Solution, on our first asses, the regulatory staff agreed that the BE
criteria --> Pharmacokinetic parameters were measured from Diazepam in
plasma.
But the second visit, the regulatory staff changed her policy, the BE
criteria --> Pharmacokinetic parameters were measured from Diazepam
and desmethyldiazepam in plasma.
Does any one have experience, the BE criteria get from Diazepam only
or both (Diazepam and/or desmethyldiazepam?
Pls Help me
Rgds,
Lovi
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The following message was posted to: PharmPK
Hi Lovi,
I tried to check the literature for this and few things which I want you
to notice is:
1) The regulatory for which you are looking for approval may be
important here.
2) Desmethyldiazepam usually clear BE criteria if Diazepam clears. I
mean from the literature what I got, there is no evidence that
desmethyldiazepam is variable. So you need not worry even if they ask
you to show BE for Diazepam and Desmethyldiazepam.
3) Only thing is you may incur extra cost for Desmethyldiazepam
analysis. But this is not unusual with this kind of studies.
4) Both Diazepam and Desmethyldiazepam are active and contribute to the
efficacy of the drug. So it's no surprise, if regulatory is asking you
to analyze both. Only thing that can be question in this case would be
whether BE is required to be show on both.
Bye
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