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BE criteria [Regulatives / Guidelines]

posted by rajasekharkakarla - India, 2018-08-03 09:21  - Posting: # 19130
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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

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