BE criteria [Regulatives / Guidelines]
» 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.