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maverick ☆ India, 2009-10-13 12:48 (5639 d 11:37 ago) Posting: # 4346 Views: 11,532 |
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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] |
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Helmut ★★★   Vienna, Austria, 2009-10-13 14:32 (5639 d 09:53 ago) @ maverick Posting: # 4348 Views: 9,552 |
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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); ![[image]](img/uploaded/image219.png) 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! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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patel_prakash79 ☆ India, 2009-12-03 12:07 (5588 d 11:18 ago) @ Helmut Posting: # 4412 Views: 9,456 |
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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. Reference: 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 everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2009-12-04 03:38 (5587 d 19:46 ago) @ patel_prakash79 Posting: # 4428 Views: 9,716 |
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Dear Prakash, thanks for the information - I didn't know that one! Since I don't speak Portuguese, navigating ANVISA's website is always a little bit adventurous for me - can you provide us with a link to Resolução - RDC n° 34 de 03 de junho de 2008? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Jaime_R ★★ Barcelona, 2009-12-07 03:09 (5584 d 20:15 ago) @ Helmut Posting: # 4435 Views: 14,595 |
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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). — Regards, Jaime |
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Helmut ★★★ Vienna, Austria, 2009-12-08 15:15 (5583 d 08:10 ago) @ Jaime_R Posting: # 4446 Views: 9,305 |
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— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Karupu ☆ 2010-10-04 10:29 (5283 d 13:55 ago) @ Jaime_R Posting: # 5985 Views: 8,805 |
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❝ I don't speak Portuguese also, but it was a little bit easier for me. ❝ Here it is. Dear Jaime, Can be help me to get the document (Resolution 34), as the respective link is not working by now. Thanks in advance... Karupu |
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Helmut ★★★ Vienna, Austria, 2010-10-04 16:35 (5283 d 07:49 ago) @ Karupu Posting: # 5989 Views: 8,835 |
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Dear Karapu! ❝ Can be help me to get the document (Resolution 34), as the respective link is not working by now. See the note at the guideline-collection: ANVISA is redesigning their website starting in mid-August 2010. Most links are broken with no automatic redirects as of 12 September 2008. We are trying to update links as soon as possible The new website is a nightmare - I'm too short in time to fight myself through by means of translate. Most of the time even the main-page results in a server-error (HTTP 500). Sorry. Try to contact ANVISA directly: ![[image]](img/email.png) bioequivalencia![[image]](https://static.bebac.at/img/at.png) anvisa.gov.br— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Karupu ☆ 2010-10-04 17:25 (5283 d 07:00 ago) @ Helmut Posting: # 5990 Views: 8,701 |
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Dear Schütz, Thank you for your response. I just thought that some people who downloaded the document could share... let me quire ANVISA, directly. Thanks & Regards Karupu |
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Helmut ★★★ Vienna, Austria, 2010-10-04 17:33 (5283 d 06:52 ago) @ Karupu Posting: # 5991 Views: 8,719 |
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Dear Karupu, I activated the e-mail link in your profile - others users may contact you now. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Karupu ☆ 2010-10-04 17:58 (5283 d 06:26 ago) @ Helmut Posting: # 5992 Views: 8,666 |
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Dear Schütz, No words to explain my regards, anyhow let me spell out a word, which seems to be small, but heavy weight-age one...... Thanks!!  ..- Karupu Edit:  Please call me Helmut.  |
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kartikpharma ☆ 2009-12-03 10:40 (5588 d 12:45 ago) @ maverick Posting: # 4410 Views: 9,340 |
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Dear Maverick It should be minimum 6 months as per new guideline. Regards, Kartik Patel 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 #5! [Helmut] |
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BRB ☆ Canada, 2018-04-05 02:18 (2543 d 22:06 ago) (edited on 2018-04-05 09:12) @ kartikpharma Posting: # 18642 Views: 5,476 |
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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] |
Ing. Helmut Schütz