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tulip_bhattacharjee ☆ 2010-10-18 09:43 (5734 d 14:16 ago) Posting: # 6056 Views: 5,755 |
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[b][/b][big][/big][color:blue][/color:blue] Dear All, Can you suggest me which guideline for ba/be studies to be followed for uganda market Thanx in advance Tulip  Edit: Subject line changed. [Helmut] |
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d_labes ★★★ Berlin, Germany, 2010-10-18 11:27 (5734 d 12:32 ago) @ tulip_bhattacharjee Posting: # 6057 Views: 3,211 |
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Dear Tulip, ❝ [b][/b][big][/big][color:blue][/color:blue]  Whats your hidden message? ❝ ... guideline for ba/be studies to be followed for uganda market Have you ever considered to  ?Have a look at the Uganda National Drug Authority site. And you will find http://www.nda.or.ug/docs/reg.pdf. Seems there are no distinct regulations despite some general statements. — Regards, Detlew |
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Helmut ★★★   Vienna, Austria, 2010-10-18 16:00 (5734 d 07:59 ago) @ d_labes Posting: # 6059 Views: 4,205 |
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Dear D. Labes! ❝ ❝ [b][/b][big][/big][color:blue][/color:blue] ❝ Easy - didn't find the ![[image]](img/InstrPst3.png) button...❝ Seems there are no distinct regulations despite some general statements. THX for googling; I added it to the Guidelines. Maybe WHO's GL is applicable in the meantime, following a converse argument of the GL on Variations (2009): Justification for not submitting a new bioequivalence study according to the current WHO guideline, in: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth report, 2006, Annex 7 (WHO Technical Report Series, No. 937) and Good Clinical Practices. — 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 |
Ing. Helmut Schütz