ElMag ☆ 2011-05-11 11:11 (4726 d 17:46 ago) Posting: # 7003 Views: 4,578 |
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Hello! Can anyone let me know if ANVISA accepts BE study designs recommended only by FDA or can they accept already approved EMA designs? I've tried to visit their site and your page for guidelines, but all the links were broken. . Thanks in advance! |
Helmut ★★★ Vienna, Austria, 2011-05-11 15:56 (4726 d 13:00 ago) @ ElMag Posting: # 7011 Views: 4,224 |
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Dear ElMag! ❝ Can anyone let me know if ANVISA accepts BE study designs recommended only by FDA or can they accept already approved EMA designs? According to the 'old' guidances, nothing special for ANVISA with a few exceptions:
❝ I've tried to visit their site and your page for guidelines, but all the links were broken. . Well, have you seen: Note: ANVISA is redesigning their website starting in mid-August 2010. Most links are broken with no automatic redirects as of 12 September 2010. We are trying to update links as soon as possible. I don’t speak Portuguese and don’t know anybody who does. ANVISA’s website was a nightmare from the very beginning and has not improved ever since. — 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 |
Mahesh M ★ India, 2018-07-11 11:11 (2108 d 17:45 ago) @ Helmut Posting: # 19030 Views: 2,269 |
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Dear Helmut, Do you have any references for below (NTID for ANVISA) ❝ ANVISA 95% CI within 80-125%. Regards Mahesh |
Helmut ★★★ Vienna, Austria, 2018-07-11 13:29 (2108 d 15:27 ago) @ Mahesh M Posting: # 19031 Views: 2,323 |
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Hi Mahesh, ❝ Do you have any references for below (NTID for ANVISA) ❝ ❝ ANVISA 95% CI within 80-125%. Of historical interest only… Resolution - RE nº 896, of May 29, 2003 (Official Journal of 02/06/2003) Nothing in the current one. — 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 |