2006-05-06 11:56
(6243 d 19:25 ago)

Posting: # 106
Views: 8,374

 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,

Vienna, Austria,
2006-05-06 12:21
(6243 d 19:00 ago)

@ devender_naik
Posting: # 108
Views: 6,368

 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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
 Admin contact
22,627 posts in 4,743 threads, 1,613 registered users;
17 visitors (0 registered, 17 guests [including 10 identified bots]).
Forum time: 07:22 CEST (Europe/Vienna)

Learn the rules like a pro,
so you can break them like an artist.    attributed to Pablo Picasso

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