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RegisterInclusion criteria (ANVISA) [Regulatives / Guidelines]
Dear HS,
There is a guidance for window period of study participation between two studies. however, it is applicable only to the studies to be carried out in Brazil as per my knowledge. The below is the details of respective guidance available on ANVISA website. It is available in Portuguese.
Article 7 is hereby established the minimum 6 (six) months from the date of the last hospitalization in a study and participation in a new study of bioavailability and bioequivalence studies for the same volunteer.
Referece: ANVISA - RDC No. 34 OF 3 JUNE 2008. Establishing the Information System for the Study of pharmaceutical equivalence and bioequivalence - SINEB and the National Registry of Volunteers in Studies Bioequivalence - CNVB
With regards,
Prakash
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
There is a guidance for window period of study participation between two studies. however, it is applicable only to the studies to be carried out in Brazil as per my knowledge. The below is the details of respective guidance available on ANVISA website. It is available in Portuguese.
Article 7 is hereby established the minimum 6 (six) months from the date of the last hospitalization in a study and participation in a new study of bioavailability and bioequivalence studies for the same volunteer.
Referece: ANVISA - RDC No. 34 OF 3 JUNE 2008. Establishing the Information System for the Study of pharmaceutical equivalence and bioequivalence - SINEB and the National Registry of Volunteers in Studies Bioequivalence - CNVB
With regards,
Prakash
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
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- 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
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- ANVISA’s site Karupu 2010-10-04 15:58
- ANVISA's site Helmut 2010-10-04 15:33
- ANVISA’s site Karupu 2010-10-04 15:25
- ANVISA’s site Helmut 2010-10-04 14:35
- RDC No 34 (2008) Jaime_R 2009-12-07 02:09
- RDC No 34 (2008) Helmut 2009-12-04 02:38
- Inclusion criteria (ANVISA)patel_prakash79 2009-12-03 11:07
- Inclusion criteria (ANVISA) kartikpharma 2009-12-03 09:40
- Inclusion criteria (ANVISA) BRB 2018-04-05 00:18
- Inclusion criteria (ANVISA) Helmut 2009-10-13 12:32
Ing. Helmut Schütz