ketan
☆    

India,
2012-10-12 10:57
(5007 d 02:18 ago)

Posting: # 9401
Views: 3,751
 

 Change in IS [Bioanalytics]

Post reply
Dear All,

We have to carry out pivotal study for which we have validated method in which internal standard used was not deteurated or labeled molecule, but now we are planning to go for deuterated IS and again re-validate the method before subject analysis therefore I would like to know whether this change in IS for pivotal study is acceptable to the regulatory.

Regards,
Ketan
 
Ohlbe
★★★

France,
2012-10-12 12:06
(5007 d 01:09 ago)

@ ketan
Posting: # 9402
Views: 3,005
 

 Change in IS

Post reply
Dear Ketan,

As long as you perform a full validation again (except long-term, bench-top and freeze/thaw stability, if they were obtained with a reliable and validated method), I can't see any reason why the regulatory agencies would refuse your data.

Regards
Ohlbe
—
Regards
Ohlbe
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
351 visitors (0 registered, 351 guests [including 20 identified bots]).
Forum time: 13:15 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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