Bioequivalence and Bioavailability Forum • Inclusion criteria (ANVISA)

Inclusion criteria (ANVISA) [Regulatives / Guidelines]

posted by maverick – India, 2009-10-13 12:48 (5307 d 09:59 ago) – Posting: # 4346
Views: 10,292

Dear All,
I would like to know the inclusion criteria for subjects participating in a BE study for Brazil-ANVISA submission, especially the time gap to take part in the study to its previous one and also the time interval of blood donation. I heard that it is 180 days but couldn't find the supportive guidance.

so help me out!

Best Regards,
Maverick

Edit: Subject line changed. [Helmut]

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