Imph ★ 2023-02-27 10:09 (802 d 10:42 ago) Posting: # 23476 Views: 4,111 |
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Hello! In the formulas for calculating the number of subjects on logarithmic scale, should we use the variance or the coefficient of variation? In Chow's paper (On Sample Size Calculation in Bioequivalence Trials, 2001) we see the variance in the formula on log-sclae while in his book (Design and Analysis of Bioavailability and Bioequivalence Studies, 2009) we see th coefficient of variation in the formula on log-scale. Thank you in advance. |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2023-02-27 14:00 (802 d 06:50 ago) @ Imph Posting: # 23477 Views: 3,303 |
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Hi Imph, ❝ […] should we use the variance or the coefficient of variation? In Chow's paper (On Sample Size Calculation in Bioequivalence Trials, 2001) we see the variance in the formula on log-sclae while in his book (Design and Analysis of Bioavailability and Bioequivalence Studies, 2009) we see th coefficient of variation in the formula on log-scale. Both are fine. From the ANOVA of the study’s data you get the residual variance. However, the CV is more common. If you use software, make sure to use the correct input. $$\eqalign{ CV&=\sqrt{\exp(s^2)-1}\\ s^2&=\log_{e}(CV^2+1) }$$ PS: If you want to perform the estimation manually, be aware that the formulas in Chow & Wang’s 2001 paper are only approximate and contain typos (I warned you already). See the errata: J Pharmacokinet Pharmacodyn. 2002; 29(2): 101-102. — 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 |
mittyri ★★ Russia, 2023-02-27 21:45 (801 d 23:06 ago) @ Helmut Posting: # 23478 Views: 3,333 |
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Hi Imph, Helmut and All! some history porn CV ≈ sqrt(MSE) # for low MSE only!!! Historical interest only (but still popular in NONMEM wild forests) — Kind regards, Mittyri |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2023-02-28 11:24 (801 d 09:26 ago) @ mittyri Posting: # 23479 Views: 3,319 |
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Hi mittyri, ❝ some history porn Hey, that’s a nice one! ❝ Historical interest only (but still popular in NONMEM wild forests) The Canadian guidances (from 1992 to the draft of 2009) contained these goodies:$$\eqalign{ \text{Intrasubject CV}&=100\times\text{(MSResidual)}^{0.5}\\ \text{Intersubject CV}&=100\times\text{(MSSubj}\,\text{(Seq))}^{0.5}}$$ When using the wrong formula, estimated sample sizes will be too small. Example for 2×2×2, T/R 0.95, target power 0.8:
— 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 |
Imph ★ 2023-03-06 13:42 (795 d 07:08 ago) @ Helmut Posting: # 23486 Views: 3,107 |
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Hello! thanks a lot for all these informations. Best regards. |