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mayur661 ☆ India, 2010-06-02 16:54 (5458 d 13:53 ago) Posting: # 5410 Views: 6,374 |
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We are performing Bioequivalence Study of macrolide Suspension with reference product. In every pilot BE study reference product show variation, while test product give uniform data. Due to this reason we are not getting correct bioequivalence? What is reson behind this reference product variation. Edit: See here. [Helmut] |
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Dr_Dan ★★ Germany, 2010-06-02 17:30 (5458 d 13:17 ago) @ mayur661 Posting: # 5416 Views: 4,802 |
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Please give more information: study design, dose, formulation differences? — Kind regards and have a nice day Dr_Dan |
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mayur661 ☆ India, 2010-06-03 07:38 (5457 d 23:09 ago) @ Dr_Dan Posting: # 5420 Views: 4,770 |
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❝ Please give more information: study design, dose, formulation differences? Two way cross over design 200 mg/5mL No iffrence in formulation only API have diffrent hydrate form other than refrence |
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Helmut ★★★   Vienna, Austria, 2010-06-03 14:14 (5457 d 16:33 ago) @ mayur661 Posting: # 5424 Views: 4,869 |
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This is not a military camp; no need to use a command-and-report-language. You are substantially decreasing your chances getting answers. — 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