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Irukulla Shravan Kumar ★ India, 2014-04-19 10:35 (3658 d 05:19 ago) Posting: # 12861 Views: 2,826 |
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Dear sir, one of our client is palnning to market their product in Middle east and north africa regions by conducting BA/BE studies. kindly help me out in regards to the guidlines to be followed for these regions. Regards, I.Shravan |
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Dr_Dan ★★ Germany, 2014-04-21 21:13 (3655 d 18:42 ago) @ Irukulla Shravan Kumar Posting: # 12869 Views: 2,529 |
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Dear I.Shravan Middle east and north africa, the so called MENA region covers a lot of countries. In contrast to the EU the term MENA pretends to represent a homogenous federation which is really not the case. Different countries with different legislations. Consequently no MENA guidelines exist. For some countries of the MENA region you can find guidelines under http://bebac.at/Guidelines.htm. If you conduct your BE study according to EMA guideline you will be on the safe side. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2014-04-21 21:19 (3655 d 18:36 ago) @ Dr_Dan Posting: # 12870 Views: 2,525 |
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Hi Dan & Irukulla, ❝ […] For some countries of the MENA region you can find guidelines under http://bebac.at/Guidelines.htm. I don’t bet on its completeness (see this post). I would suggest to ask a reliable translation office. ❝ If you conduct your BE study according to EMA guideline you will be on the safe side. Don’t rely on the acceptance of fancy stuff like Two-Stage Designs, Reference-scaling for HVDs/HVDPs, Biowaivers for BCS III drugs… — 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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Dr_Dan ★★ Germany, 2014-04-22 14:37 (3655 d 01:18 ago) @ Helmut Posting: # 12872 Views: 2,397 |
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Hi Helmut ❝ Don’t rely on the acceptance of fancy stuff like Two-Stage Designs, Reference-scaling for HVDs/HVDPs, Biowaivers for BCS III drugs… I totally agree. I was referring to the general 2way cross-over and parallel design with respect to primary parameters, confidence intervals and acceptance criteria.... Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Irukulla Shravan Kumar ★ India, 2014-04-24 09:20 (3653 d 06:35 ago) @ Dr_Dan Posting: # 12879 Views: 2,400 |
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Dear Helmut and Dan, Thanking you so much for your valuable support. Regards, I.Shravan |
Ing. Helmut Schütz