Bioequivalence and Bioavailability Forum • Inclusion criteria (ANVISA)

Inclusion criteria (ANVISA) [Regulatives / Guidelines]

posted by BRB – Canada, 2018-04-05 02:18 (2212 d 07:29 ago) – Posting: # 18642
Views: 4,461
(edited by Ohlbe on 2018-04-05 09:12)

Hello all,

❝ It should be minimum 6 months as per new guideline.

Is the 6 month time frame only between studies for ANVISA submission? I would think that's the case.

Hypothetically, could a subject participate in another study for another agency (e.g. the FDA) 30 days after doing a study for ANVISA taking into account their 6 month lock out requirement?

Thanks!
BRB

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Inclusion criteria (ANVISA) maverick 2009-10-13 10:48
- Inclusion criteria (ANVISA) Helmut 2009-10-13 12:32
  - Inclusion criteria (ANVISA) patel_prakash79 2009-12-03 11:07
    - RDC No 34 (2008) Helmut 2009-12-04 02:38
      - RDC No 34 (2008) Jaime_R 2009-12-07 02:09
        
        RDC No 34 (2008) Helmut 2009-12-08 14:15
        RDC No 34 (2008) Karupu 2010-10-04 08:29
        
        ANVISA’s site Helmut 2010-10-04 14:35
        
        ANVISA’s site Karupu 2010-10-04 15:25
        
        ANVISA's site Helmut 2010-10-04 15:33
        
        ANVISA’s site Karupu 2010-10-04 15:58
- Inclusion criteria (ANVISA) kartikpharma 2009-12-03 09:40
  - Inclusion criteria (ANVISA)BRB 2018-04-05 00:18