Bioequivalence and Bioavailability Forum

Inclusion criteria (ANVISA) [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2009-10-13 14:32 (5301 d 16:02 ago) – Posting: # 4348
Views: 8,515

Dear Maverick!

❝ I would like to know the inclusion criteria for subjects participating in a BE study for Brazil-ANVISA submission,…

Nothing special. See ANVISA's guideline from 2003: Annex, Section 1.i)-m)
Nothing changed in the current (2006) guideline (Section 1.k)-p) in Portuguese only); translate.
Of course you have to adapt inclusion criteria to your drug's effect/AE-profile.

❝ … especially the time gap to take part in the study to its previous one and also the time interval of blood donation. […] but couldnt find the supportive guidance.

Me not either. In my experience ANVISA is always open for questions; for the current contact point see this post.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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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