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RegisterGlatiramer Acetate [Design Issues]
Dear Chirag
I do not understand why you have to conduct a BE study since your formulation is a solution for subcutaneous injection. The only excipient of the RLD is mannitol and if you do not use a different excipient there should be no formulation effect and consequently a BE study is not necessary.
Please explain.
Thanks in advance.
Kind regards
Dr_Dan
I do not understand why you have to conduct a BE study since your formulation is a solution for subcutaneous injection. The only excipient of the RLD is mannitol and if you do not use a different excipient there should be no formulation effect and consequently a BE study is not necessary.
Please explain.
Thanks in advance.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Glatiramer Acetate cakhatri 2014-03-02 14:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Glatiramer AcetateDr_Dan 2014-03-03 12:23
- Glatiramer Acetate nobody 2014-03-03 13:06
- Glatiramer Acetate drgunasakaran1 2014-03-06 17:26
- Glatiramer Acetate nobody 2014-03-07 11:48
Ing. Helmut Schütz