qualityassurance
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2023-10-02 14:06
(988 d 08:28 ago)

Posting: # 23728
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 Pilot study data submission as pivotal study [Off Topic]

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Dear forum members,

If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects?

Interesting to know the opinions.

Thank you.
Regards,
QA
 
dshah
★★  

India,
2023-10-03 18:30
(987 d 04:05 ago)

@ qualityassurance
Posting: # 23733
Views: 4,441
 

 Pilot study data submission as pivotal study

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Dear QA!

❝ If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects?


If your batch size/scale remains same, was manufactured under cGMP condition, it could be used.

Regards,
Divyen
 
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