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Registersmall peptide = pure generic? [Regulatives / Guidelines]
Hi Dan,
This is case-by-case and even between agencies the opinions differ.
If I were you I would look into the original form of the peptide. If there is one form (only!) quantitatively, and if the copycat is exactly that same form quantitatively, then you will have some chance to convince the regulators of a true generic submission.
You cannot find more info in the public domain, I think, and it is a little like the wind blows.
So get scientific advice. And bring an apple.
❝ However this sounds quite vague and I would like to know the prerequisites to follow the simple approach. Where can I find more Information? Of course it is a case by case decision but it would be helpful to know the pitfalls.
This is case-by-case and even between agencies the opinions differ.
If I were you I would look into the original form of the peptide. If there is one form (only!) quantitatively, and if the copycat is exactly that same form quantitatively, then you will have some chance to convince the regulators of a true generic submission.
You cannot find more info in the public domain, I think, and it is a little like the wind blows.
So get scientific advice. And bring an apple.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- small peptide = pure generic? Dr_Dan 2015-02-17 18:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- small peptide = pure generic?ElMaestro 2015-02-17 19:40
- small peptide = pure generic? nobody 2015-02-17 22:25
- small peptide = pure generic? VK 2015-02-19 17:07
- small peptide = pure generic?ElMaestro 2015-02-17 19:40
Ing. Helmut Schütz