devender_naik
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Hyderabad,
2006-05-06 11:56
(6588 d 00:31 ago)

Posting: # 106
Views: 9,124
 

 Inclusion and Exclusion [Regulatives / Guidelines]

Dear all,

Can any one let me know the time gap for a volunteer to participate in a study and also the weight range as per ANVISA.

Thank You,
Devender

dd
Helmut
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Vienna, Austria,
2006-05-06 12:21
(6588 d 00:06 ago)

@ devender_naik
Posting: # 108
Views: 6,930
 

 Inclusion and Exclusion (ANVISA)

Dear Devender,

I don't think that there is a specific time interval mentioned in any of ANISA's regulations.

Concerning the weight range: the last regulation was published on 19 Apr 2006 and presently is available only in Portuguese; the text has not changed from previous versions (the weight of the subjects must be within a limit of ± 15% of the weight considered normal for men and women, considering height and physical structure).

(Annex, 1. Clinical stage, paragraph l)

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