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RegisterA strange question from my formulator friends [Regulatives / Guidelines]
Dear john
Approaching FDA, with a BE results using two or 3 lots of a reference product (same country, same product, just a different batch/lot) where even if your product is BE to all except one is futile.
Tried once (luckily it was a very small scale pilot) and regretted it!!
If you will talk about HVD/HVDP they will simply suggest RSABE.
My two cents!!!
Approaching FDA, with a BE results using two or 3 lots of a reference product (same country, same product, just a different batch/lot) where even if your product is BE to all except one is futile.
Tried once (luckily it was a very small scale pilot) and regretted it!!
If you will talk about HVD/HVDP they will simply suggest RSABE.
My two cents!!!
—
~A happy Soul~
~A happy Soul~
Complete thread:
- A strange question from my formulator friends jag009 2013-08-03 23:23
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- A strange question from my formulator friendsluvblooms 2013-08-05 06:22
- A strange question from my formulator friends jag009 2013-08-05 15:38
- A strange question from my formulator friendsluvblooms 2013-08-05 06:22
Ing. Helmut Schütz