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RegisterGlatiramer Acetate [Design Issues]
Dear Members,
We have a requirement on conduct of study on Glatiramer acetate injection (20mg) for USFDA submission. The study is to be conducted in India. There are no FDA guidelines on conduct of the study for ANDA submission.Can anyone share their experience in conducting study with this molecule
Regards
Chirag
We have a requirement on conduct of study on Glatiramer acetate injection (20mg) for USFDA submission. The study is to be conducted in India. There are no FDA guidelines on conduct of the study for ANDA submission.Can anyone share their experience in conducting study with this molecule
Regards
Chirag
Complete thread:
- Glatiramer Acetatecakhatri 2014-03-02 14:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Glatiramer Acetate Dr_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