Bioequivalence and Bioavailability Forum

RDC No 34 (2008) [Regulatives / Guidelines]

posted by Jaime_R – Barcelona, 2009-12-07 03:09 (5253 d 06:47 ago) – Posting: # 4435
Views: 13,553

Hi Helmut!

I don't speak Portuguese also, but it was a little bit easier for me.
Here it is.

Article 1
§2: Sistema de Informações em Estudos de Equivalência Farmacêutica e Bioequivalência - SINEB (information system in studies of pharmaceutical equivalence and bioequivalence)
§3: Cadastro Nacional de Voluntários em Estudos de Bioequivalência - CNVB (national registry of volunteers in BE studies, where CNVB is a part of SINEB located at ANVISA)
Article 7
A minimum of 6 (six) months from the date of the last hospitalization in a study and participation in a new BA/BE study for the same volunteer is mandatory.

The resolution is in force with the date of publication (04 June 2008).

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