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RegisterPositive Pre-dose in subsequent period of long acting depot injection [Design Issues]
Dear All,
Does FDA raise any concern if we get around 20 to 25% positive pre-dose concentration in subsequent period of the study? Please note that the product is long acting depot injection and wash out duration fixed based on the data available on FDA site under SBOA for reference product.
Please share your advice/ comment in this regard.
Regards,
Compliance
Does FDA raise any concern if we get around 20 to 25% positive pre-dose concentration in subsequent period of the study? Please note that the product is long acting depot injection and wash out duration fixed based on the data available on FDA site under SBOA for reference product.
Please share your advice/ comment in this regard.
Regards,
Compliance
Complete thread:
- Positive Pre-dose in subsequent period of long acting depot injectionCompliance 2015-10-14 12:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exclusion of subjects Helmut 2015-10-14 14:44
- Positive Pre-dose in subsequent period of long acting depot injection ElMaestro 2015-10-14 22:37
- Positive Pre-dose in subsequent period of long acting depot injection Compliance 2015-10-15 07:36
- Expected loss in power Helmut 2015-10-15 13:45
- Positive Pre-dose in subsequent period of long acting depot injection Compliance 2015-10-15 07:36
Ing. Helmut Schütz