shyam_5p
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India,
2012-01-03 10:05
(5291 d 06:23 ago)

Posting: # 7855
Views: 2,402
 

 Harmonization of BE study [Regulatives / Guidelines]

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Request for discussion on harmonization of BE study in US and EU

Many a times the Innovator (RLD) is manufactured at one site with same qualitative composition and other physical parameters. But as per my knowledge when the generic company wanted to file the products to US and EU, they usually study separate BE study for US and EU with the respective country RLD (nothing but same). Request all to comment on same.
 
Helmut
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Vienna, Austria,
2012-01-03 15:13
(5291 d 01:15 ago)

@ shyam_5p
Posting: # 7857
Views: 2,007
 

 FDA vs. EMA (“same” reference?)

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Dear Shyam!

What about a less laconic posting style next time? ;-) Your question has been raised (and answered) already numerous times; see f.i. here.
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