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sagar ☆ India, 2011-04-28 14:19 (5539 d 06:17 ago) Posting: # 6962 Views: 4,117 |
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Is it mandatory for malaysian regulatory authority to approve the centre for carrying BE centre before conducting BE studies. Many Malysian companies have this assumption. Also, is it required to carry clinical part in Thai population for Thai MOH study. May I request to send me document (if any) which proves that above two statments are wrong. |
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Helmut ★★★   Vienna, Austria, 2011-04-28 20:17 (5539 d 00:20 ago) @ sagar Posting: # 6969 Views: 3,562 |
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Dear Sagar! See the Policy. THX. ❝ Is it mandatory for malaysian regulatory authority to approve the centre ❝ for carrying BE centre before conducting BE studies. Many Malysian ❝ companies have this assumption. I don't think so (see 2000 GL). ❝ Also, is it required to carry clinical part in Thai population for Thai ❝ MOH study. Not according to the 2005 GL. The current version is only available in ภาษาไทย. ![[image]](img/uploaded/image219.png) -translate doesn't give me such an impression. There are only some minor specificities, like an upper limit of the BMI of 24 kg/m².❝ May I request to send me document (if any) which proves that above two ❝ statments are wrong. I activated your e-mail link. — 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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YT ☆ Thailand, 2011-04-29 05:41 (5538 d 14:55 ago) @ sagar Posting: # 6971 Views: 3,545 |
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Dear Sagar, Try this for Thai guideline http://wwwapp1.fda.moph.go.th/drug/zone_law/files/drug100_EN.pdf Regards, YT |
Ing. Helmut Schütz