junhao ☆ China, 2016-04-18 12:15 (3261 d 04:19 ago) Posting: # 16210 Views: 8,357 |
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Dear All, I see everybody is refering this famous reference but where exactly can I find or buy it? I searched in the forum and google for hours but failed anyway to find the full-text reference. Does anyone really have this full-text reference at hand? Could you share where and how you get it? Appreciate it so much! 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) Best regards, Junhao// |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2016-04-18 15:22 (3261 d 01:12 ago) @ junhao Posting: # 16211 Views: 7,266 |
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Hi Junhao, you can try to get it from the the Publishers (Dustri-Verlag, contact Petra Estner). Alternatively you could ask Dieter Hauschke for a copy. If that doesn’t work I can scan my copy (will be lousy: yellowed and with notes in the margins…). It is a very interesting paper if you want to understand the background of sample size estimation. For practical use less so. The tables are for 70/80/90% power, T/R-ratios of 0.85–1.20 (step size 0.05), and CVs of 5–30% (step size 2.5%). Power curves are highly nonlinear. If you want anything which is not covered in the tables, interpolation is not a good idea. If you want to estimate sample sizes for any desired power, ratio, and CV I recommend the package PowerTOST for R (freeware!). In PowerTOST many designs are covered (two parallel groups, paired means, crossovers: 2×2×2, 3×3, 3×6×3, replicates: 2×2×4, 2×2×3, 2×4×4, partial 2×3×3, Balaam’s 2×4×2, Liu’s 2×2×2). Additionally to power / sample size for conventional average bioequivalence other methods are supported: Reference-scaling for HVD(P)s according to the FDA’s, EMA’s, and ANVISA’s requirements; RSABE for NTIDs (FDA); noninferiority, ratio of means (Fieller’s CI), dose proportionality (power model). Check out the online-manual.— 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 |
d_labes ★★★ Berlin, Germany, 2016-04-18 21:28 (3260 d 19:06 ago) @ Helmut Posting: # 16214 Views: 6,989 |
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Dear Helmut, dear Junhao! ❝ ... If you want to estimate sample sizes for any desired power, ratio, and CV I recommend the package [nitpicking] R is free software which comes with source code (open source). Package BTW: @Helmut what's that 'Hero' below my user name in the post pane? — Regards, Detlew |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2016-04-19 02:03 (3260 d 14:31 ago) @ d_labes Posting: # 16215 Views: 6,932 |
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Dear Detlew, ❝ [nitpicking] ❝ [/nitpicking] Oops, correct! ❝ BTW: @Helmut what's that 'Hero' below my user name in the post pane? Hover over it. It categorizes members by their number of contributions. Only four others reached the level you are in… ![]() I don’t care to belong to any club that will have me as a member. Groucho Marx — 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 |
d_labes ★★★ Berlin, Germany, 2016-04-19 11:14 (3260 d 05:20 ago) @ Helmut Posting: # 16219 Views: 6,922 |
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Dear Helmut, ❝ I don’t care to belong to any club that will have me as a member. Groucho Marx Full ACK ![]() — Regards, Detlew |
junhao ☆ China, 2016-04-19 07:37 (3260 d 08:57 ago) @ d_labes Posting: # 16218 Views: 7,045 |
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Dear Detlew, ❝ R is free software which comes with source code (open source). Package ❝ That's distinct from freeware. ❝ But that is of course an only puristic note or for lawyers dealing with licenses Thank you for letting me know the difference ![]() And I am surprised to recognize that you must also be one of the authors of the R package! I love you heroes so much for making such amazing tools! ![]() Best regards, Junhao// |
d_labes ★★★ Berlin, Germany, 2016-04-19 11:54 (3260 d 04:40 ago) @ junhao Posting: # 16220 Views: 6,833 |
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Dear Junhao, ❝ And I am surprised to recognize that you must also be one of the authors of the R package ... Too bad that this well-kept secret now is disclosed ![]() I'm in respectable society. Try in R:
Remember the guy called 'Maintainer' in the DESCRIPTION file if you encounter problems in trying PowerTOST. — Regards, Detlew |
junhao ☆ China, 2016-04-19 07:26 (3260 d 09:08 ago) @ Helmut Posting: # 16216 Views: 6,995 |
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Dear Helmut, ❝ you can try to get it from the the Publishers (Dustri-Verlag, contact Petra Estner). Alternatively you could ask Dieter Hauschke for a copy. Thank you for your quick reply and kind offer! I thought the paper would be an interesting and important one to help me understand the background of sample size estimation and the whole statistical considerations of BE testing. I will follow what you have told me, try to ask Petra Estner and Dieter Hauschke first for a copy. I will also try the PowerTOST in R later and I appreciate you as one of the authors of the R package! Thank you for your help again Helmut and all the best, Junhao// |