ketan
☆    

India,
2012-10-12 10:57
(4611 d 16:07 ago)

Posting: # 9401
Views: 3,104
 

 Change in IS [Bioanalytics]

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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
(4611 d 14:59 ago)

@ ketan
Posting: # 9402
Views: 2,487
 

 Change in IS

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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
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Regards
Ohlbe
 
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