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RegisterBE criteria [Regulatives / Guidelines]
Dear All,
I prepared protocol for XX drug and when at the time of protocol preparation based on supportive literature i assumed it is a NTI durg and i written BE criteria as 90.00 to 111.00% CI. Later after completion of PK analysis the report writer without referring protocol he conclude BE based on 80.00 to 125.00 % CI and study has passed. but as per protocol criteria it is not meeting BE criteria i.e. 90.00 to 111.00 % CI. after rigorous literature work done and based on OGD we finally concluded the drug is not a NTI. Now i confused whether i need to go for amendment to protocol to modify BE criteria. Is it acceptable after PK and statistical analysis.
Regards,
Rajasekhar K
I prepared protocol for XX drug and when at the time of protocol preparation based on supportive literature i assumed it is a NTI durg and i written BE criteria as 90.00 to 111.00% CI. Later after completion of PK analysis the report writer without referring protocol he conclude BE based on 80.00 to 125.00 % CI and study has passed. but as per protocol criteria it is not meeting BE criteria i.e. 90.00 to 111.00 % CI. after rigorous literature work done and based on OGD we finally concluded the drug is not a NTI. Now i confused whether i need to go for amendment to protocol to modify BE criteria. Is it acceptable after PK and statistical analysis.
Regards,
Rajasekhar K
Complete thread:
- BE criteriarajasekharkakarla 2018-08-03 09:21 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE criteria jag009 2018-08-06 20:35
Ing. Helmut Schütz