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RegisterIron Sucrose [Design Issues]
Hello friends,
OGD recomendation for Iron Sucrose Injection suggest Parallel design even though the half life is around 6-7 hrs. What can be the rationale for it?
Along with it they also recommend reference replicate design if one suspects high variability.
Can anyone explain the stand/thinking of USFDA on this?
Regards,
Hiren
OGD recomendation for Iron Sucrose Injection suggest Parallel design even though the half life is around 6-7 hrs. What can be the rationale for it?
Along with it they also recommend reference replicate design if one suspects high variability.
Can anyone explain the stand/thinking of USFDA on this?
Regards,
Hiren
Complete thread:
- Iron Sucrosehiren379 2012-09-11 06:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Iron Sucrose auditor 2012-09-11 11:31
- Iron Sucrose drgunasakaran1 2012-09-12 14:40
- Iron Sucrose hiren379 2012-09-12 15:35
Ing. Helmut Schütz