Posting: # 19130
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.
Posting: # 19156
» I prepared protocol for XX drug and when at the time of protocol preparation based on supportive...
Is the NTI criteria stated in the BE guidance for XX drug or there is no BE guidance from OGD?
You need a note to file saying the wrong analysis was carried out. Why you want to amend the protocol since you have literatures to support that XX drug is NTI and the protocol states that analysis be carried out based on NTI criteria.