madhavaraob
☆    

2011-04-15 13:23
(5554 d 04:15 ago)

Posting: # 6905
Views: 3,138
 

 Argentina regulatory requirements for BE study [Regulatives / Guidelines]

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Dear All,

we would like to know the requirements for BE study of Argentina regulatory. For Argentina regulatory submission, BE study need to be done on the subject population of Argentina or we can plan any where in the world? or otherwise please provide us the english tranalated version of Argentina BE guidance if any body have.

Regards,

Madhav
 
Jaime_R
★★  

Barcelona,
2011-04-16 16:25
(5553 d 01:13 ago)

@ madhavaraob
Posting: # 6912
Views: 2,808
 

 ANMAT 5040-2006

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Dear Madhav,

❝ we would like to know the requirements for BE study of Argentina regulatory.

❝ For Argentina regulatory submission, BE study need to be done on the subject

❝ population of Argentina or we can plan any where in the world?


See Argentinia's Guidelines. Nothing is mentioned in the current BA/BE-GL (September 2006, amended March 2007). Note that the mentioned GCP-GL (ANMAT 5330/97, 1997, amended 2005) is superseded by Resolución 1490/2007 (November 2007).

❝ or otherwise please provide us the english tranalated version of

❝ Argentina BE guidance if any body have.


I do speak Spanish :-D, but I'm not a translator...
—
Regards, Jaime
 
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