rajasekharkakarla
☆    

India,
2018-08-03 11:21
(2064 d 12:05 ago)

Posting: # 19130
Views: 4,455
 

 BE 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
jag009
★★★

NJ,
2018-08-06 22:35
(2061 d 00:51 ago)

@ rajasekharkakarla
Posting: # 19156
Views: 3,358
 

 BE criteria

Hi,

❝ 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.

John
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
80 visitors (0 registered, 80 guests [including 9 identified bots]).
Forum time: 22:26 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5