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Jay ☆ India, 2014-11-11 07:21 (4246 d 03:31 ago) Posting: # 13854 Views: 6,824 |
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Dear friends, For highly variable drugs with intrasubject CV more than 30% we go for partial replicate, reference replicated study design. If we are proceeding with such HVDP, is the partial reference replicated study design for pilot study recommended? Thanks in advance. Regards, Jay |
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Dr_Dan ★★ Germany, 2014-11-11 10:08 (4246 d 00:44 ago) @ Jay Posting: # 13855 Views: 5,603 |
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Dear Jay If you already know that the reference product is a HVDP what would be the advantage of a partial reference replicated study design for pilot study? Where is the gain of knowledge compared to a two-way crossover study? You might get a better idea of the magnitude of variability of the reference product (not your own formulation!, however, this could be important for studies according to EMA regulation). A Pilot study is needed to find out where you stand with your formulation and IMHO you should rather have more Test/Reference comparisons than comparisons within Reference. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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Jay ☆ India, 2014-11-11 12:03 (4245 d 22:49 ago) @ Dr_Dan Posting: # 13856 Views: 5,518 |
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Dear Dr_Dan, Thanks for the reply. |
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Helmut ★★★   Vienna, Austria, 2014-11-11 12:31 (4245 d 22:21 ago) @ Jay Posting: # 13857 Views: 5,647 |
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Dear Jay, ❝ For highly variable drugs with intrasubject CV more than 30% we go for partial replicate, reference replicated study design. Why the lousy TRR|RRT|RTR? Hint: Search the forum. — 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