completely new strength [Regulatives / Guidelines]

posted by Clarc Homepage – Romania, 2013-10-21 12:45 (4628 d 22:33 ago) – Posting: # 11715
Views: 4,217

Dear all

After going through a lot of documents and guides, I've understood that in these cases, three different studies should be conducted to assess the pharmacokinetics of the newly formulated (new strength) drug.
The absolute bioavailability, food effects and dose proportionality have to be determined.

Since there is already a publicated study in this regard, performed on ​​the original product, do You think is it possible to skip the absolute-BA or/and the food effect, or there is a need to perform all three of them?
Would it make sense to think about performing a dose proportionality test between the 70 mg test and the 100 mg reference, or would it make sense to develop a 100 mg test, perform a bioequivalence trial for the 100 mg strength, and after this bioequivalence is demonstrated, the 35 mg and 70 mg strength to be submitted, based on a dose proportionality studty???

Thanks

I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello

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