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RegisterMENA GLs [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2014-04-21 21:19 (4448 d 12:07 ago) – Posting: # 12870
Views: 3,795
Hi Dan & Irukulla,
I don’t bet on its completeness (see this post). I would suggest to ask a reliable translation office.
Don’t rely on the acceptance of fancy stuff like Two-Stage Designs, Reference-scaling for HVDs/HVDPs, Biowaivers for BCS III drugs…
❝ […] 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
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
Complete thread:
- Guidelines on middle east and north africa Irukulla Shravan Kumar 2014-04-19 08:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Guidelines on middle east and north africa Dr_Dan 2014-04-21 19:13
Ing. Helmut Schütz