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vish14184 ★ India, 2007-07-06 15:34 (6929 d 16:26 ago) Posting: # 867 Views: 4,672 |
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Dear all. please give me information about how to design replicate study? please give me referense of this type of study. thanks in advanse With regards vishal nakrani |
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H_Rotter ★ Germany, 2007-07-06 17:38 (6929 d 14:22 ago) @ vish14184 Posting: # 868 Views: 3,822 |
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Dear Vishal, have a look at this thread. Further information at Helmut's News Collection on Highly Variable Drugs: http://bebac.at/news/2006-04-27.htm http://bebac.at/news/2006-10-06.htm Hermann |
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shankar ★ India, 2007-07-11 08:13 (6924 d 23:48 ago) (edited on 2007-07-11 10:40) @ vish14184 Posting: # 875 Views: 3,658 |
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Dear vishal, Replicate study designs are recommended for BE studies of modified-release dosage forms and highly variable drug products (within-subject coefficient of variation ≥30%), including those that are immediate release, modified-release, and other orally administered drug products. Please refer attached link of FDA guidelines. Regards, Shankar NJ I edited your post removing UTF-16 (2 Byte Unicodes) from the text. Please use the before posting. [HS] Edit: Link corrected for FDA’s new site. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2007-07-11 15:22 (6924 d 16:39 ago) @ shankar Posting: # 882 Views: 3,740 |
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Dear Shankar! ❝ Replicate study designs are recommended for BE studies of modified-release dosage forms […] Do you have any current reference supporting this claim of yours? — 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