devender_naik
☆    

Hyderabad,
2006-05-06 11:56
(6536 d 16:14 ago)

Posting: # 106
Views: 8,894
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2006-05-06 12:21
(6536 d 15:49 ago)

@ devender_naik
Posting: # 108
Views: 6,751
 

 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)

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
88 visitors (0 registered, 88 guests [including 4 identified bots]).
Forum time: 03:11 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5