raghavendra_s
★    

2010-03-01 16:49
(5963 d 06:33 ago)

Posting: # 4841
Views: 3,363
 

 Key differences in US FDA, EMEA, DCGI [Regulatives / Guidelines]

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Dear Madam/Sir,

May I request summary key differences in US FDA, EMEA, DCGI guidance on BE studies in fasted, fed conditions.

Thanks in advance.
 
bharat
☆    

India,
2010-03-11 09:04
(5953 d 14:18 ago)

(edited on 2010-03-11 10:00)
@ raghavendra_s
Posting: # 4892
Views: 2,687
 

 Key differences in US FDA, EMEA, DCGI

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Dear
Pls.see below main diff.
       BMI                    water    fasting               water restriction
USFDA  LIC chart can be used   240 ml  at least 10 hrs       1 hr pre and post dose
EMEA   BMI Compulsary         >150 ml  at least 8 hrs (new)  1 hr pre and post dose (new)

DCGI AS FDA

regards
bharat

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
 
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