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manojkarwa ☆  New Delhi, 2008-04-01 15:31 (6647 d 20:54 ago) Posting: # 1738 Views: 8,804 |
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Dear Sir, I have done NCA modeling followed by Bioequivalence testing in WinNonLin software. What are the different parameter from the WinNonLin bioequivalence output can be used for the calculation of sample size for a pivotal study or is it possible to get sample size output from WinNonLin. Best Regards — Manoj Karwa, Project Manager, Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi-110015 Phone 011-45072314 |
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Helmut ★★★  Vienna, Austria, 2008-04-01 16:08 (6647 d 20:17 ago) @ manojkarwa Posting: # 1740 Views: 7,595 |
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Dear Manoj! ❝ What are the different parameter from the WinNonLin bioequivalence output ❝ can be used for the calculation of sample size for a pivotal study [...] You need CVintra and the point estimate (PE). In WinNonlin's terminology: Intrasubject CV and Ratio(%Ref)For a 2×2 design CVintra is directly given in the output (example in this post), for a William's design (more than two treatments, unreplicated) you have to calculate it manually from the residual variance (example in this post). ❝ [...] or is it possible to get sample size output from WinNonLin. No. You will have to use tables, approximations or specialized software. Please search the forum for further informations. — 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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manojkarwa ☆ New Delhi, 2008-04-02 10:48 (6647 d 01:37 ago) @ Helmut Posting: # 1743 Views: 7,329 |
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Helmut ★★★ Vienna, Austria, 2008-04-02 13:06 (6646 d 23:19 ago) @ manojkarwa Posting: # 1747 Views: 7,204 |
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Dear Manoj! ❝ Can you please give me the reference of table from where i can calculate the sample size on basis of intrasubject CV and Ratio (%Ref). Please do your homework first. Yesterday I asked you to use the search feature of the forum (the reference is given in result #15); refining the search for the terms "sample size estimation table" it's in result #3...  Diletti E, Hauschke D and VW Steinijans Sample size determination for bioequivalence assessment by means of confidence intervals Int J Clin Pharm Ther Toxicol 29(1), 1–8 (1991) — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz