bharat
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India,
2010-02-16 10:30
(5979 d 08:28 ago)

Posting: # 4768
Views: 3,764
 

 ICH E3 report for Bioequivalence [Regulatives / Guidelines]

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Dear all

Is there any guidence document for the FDA submission that the Clinical Report (For BE Study) should go according to ICH E3 Guidelines?

Thanks in advance

Regards
Bharat Narnavar
 
Helmut
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Vienna, Austria,
2010-02-16 15:10
(5979 d 03:48 ago)

@ bharat
Posting: # 4771
Views: 4,411
 

 ICH E3 report for Bioequivalence

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Dear Bharat

❝ Is there any guidence document for the FDA submission that the Clinical

❝ Report (For BE Study) should go according to ICH E3 Guidelines?


Instead of looking for a guidance for everything use deductive logic:
Are the USA one of the three ICH regions? [image]
Is a BE study a clinical study? [image]
So?

BTW, why didn't you consult the Guidances first?
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Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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