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RegisterPositive Pre-dose in subsequent period of long acting depot injection [Design Issues]
Dear Helmut & Elmaestro,
Thank you very much for sharing your concern. Expiry of reference product is only one year and we are planning to conduct 3-WSABE study due to high variability. Due to this we could not keep long wash out period. however we are taking chance that if pre dose >5 % would be higher then it would not been considered for the BE.
We performed one pilot study and my question comes from that study only. In which we got total 13 subject out of 48 with positive pre dose. Out of 13, 09 subject has shown > 5% pre dose concentration.
Regards,
Compliance
Thank you very much for sharing your concern. Expiry of reference product is only one year and we are planning to conduct 3-WSABE study due to high variability. Due to this we could not keep long wash out period. however we are taking chance that if pre dose >5 % would be higher then it would not been considered for the BE.
We performed one pilot study and my question comes from that study only. In which we got total 13 subject out of 48 with positive pre dose. Out of 13, 09 subject has shown > 5% pre dose concentration.
Regards,
Compliance
Complete thread:
- Positive Pre-dose in subsequent period of long acting depot injection Compliance 2015-10-14 12:54 [Design Issues]
![[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 injectionCompliance 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 injectionCompliance 2015-10-15 07:36
Ing. Helmut Schütz