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Irene_I ☆ Indonesia, 2018-05-16 11:02 (2309 d 08:34 ago) Posting: # 18768 Views: 5,849 |
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Dear all, My name is Irene and I'm a newcomer in bioequivalence fields. I would like to ask some question about imbalanced datasets. I have a problem in analyzing 2-treatment, 2-sequence, 2-period crossover bioequivalence study design with imbalanced datasets between sequence. I have looked for this topics and I found a similar problem here but It seems like nothing has concluded. I'm Sorry but I still do not understand about it. I conducted a data analysis for imbalance datasets from a journal entitled "Reference Dataset for 2-Treatment, 2-sequence, 2-period bioequivalence studies" (Dataset C) with EquivTest 2.0 and I compared the results with the ones stated in journal. I found that Equivtest 2.0 result (Point of estimate and 90% Confidence Interval) was not identical with EquivTest/PK (the result that stated in the journal). My Equivtest 2.0 result for point of estimates and confidence interval were: point of estimate (90% CI) : 66.78 (44.94,99.24) The result according to Journal (EquivTest/PK) point of estimate (90% CI) : 58.56 (39.41,87.03) So, is there someone could help me with this problem?  I strongly appreciate if you could help me about this matter.  Best Regards, Irene |
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Helmut ★★★   Vienna, Austria, 2018-05-16 13:47 (2309 d 05:48 ago) @ Irene_I Posting: # 18769 Views: 6,065 |
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Hi Irene, ❝ I conducted a data analysis for imbalance datasets from a journal entitled "Reference Dataset for 2-Treatment, 2-sequence, 2-period bioequivalence studies" (Dataset C) with EquivTest 2.0 and I compared the results with the ones stated in journal. I found that Equivtest 2.0 result (Point of estimate and 90% Confidence Interval) was not identical with EquivTest/PK (the result that stated in the journal). My Equivtest 2.0 result for point of estimates and confidence interval were: ❝ ❝ point of estimate (90% CI) : 66.78 (44.94,99.24) ❝ ❝ The result according to Journal (EquivTest/PK) ❝ point of estimate (90% CI) : 58.56 (39.41,87.03) Congratulations! You discovered yet another defective software.  The result in EquivTest/PK agrees with ones of other software we have tested (SAS, Phoenix/WinNonlin, R). Screenshot:
The result you got in EquivTest 2.0 agrees with Kinetica 5.01 – which is wrong.1 Amazingly enough the correct formula taking the number of subjects / sequence (n1, n2) into account is given in the “User Reference Manual”, Chapter 8: Equivalence Testing (p. 166, p. 188 of the PDF) of v2.0 (dated 2001-10-12):
Did the developers update the manual but not the code‽ Anyhow, even if you upgrade to EquivTest/PK (of 2006)2 sooner or later you will face other problems. The Welch/Satterthwaite correction for parallel designs with unequal group sizes and/or unequal variances is not supported.3 Furthermore, you will not be able to assess replicate studies intended for reference-scaling according to regulatory requirements (FDA, EMA, WHO, ASEAN States, Australia, Brazil, Egypt, the Russian Federation, the Eurasian Economic Union, New Zealand). I strongly suggest to get ‘better’ software.
— 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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Irene_I ☆ Indonesia, 2018-05-21 10:19 (2304 d 09:16 ago) @ Helmut Posting: # 18791 Views: 4,789 |
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Hi Helmut, Thank you for the information. Do you have software recommendation? Is there any problem in analyzing 2-sequence, 2-period, 2-treatment bioequivalence study with SAS? I would be grateful for your help and I look forward to your reply. Regards, Irene |
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Helmut ★★★ Vienna, Austria, 2018-05-21 19:00 (2304 d 00:36 ago) @ Irene_I Posting: # 18795 Views: 4,783 |
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Hi Irene, ❝ Do you have software recommendation? The ones we compared in our paper should do (except Kinetica, of course). I guess that at least Statistica, SPSS, STaTa, and JMP (“poor man’s SAS”) will do as well. However, it is your job to validate the installation on your machine. ❝ Is there any problem in analyzing 2-sequence, 2-period, 2-treatment bioequivalence study with SAS? If you can afford the license, no. — 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 |
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Irene_I ☆ Indonesia, 2018-06-07 12:56 (2287 d 06:40 ago) @ Helmut Posting: # 18860 Views: 4,539 |
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Hi Helmut, Thank you for your recommendation. It helps me a lot. Best Regards, Irene I |
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ElMaestro ★★★ Denmark, 2018-05-16 16:07 (2309 d 03:29 ago) @ Irene_I Posting: # 18770 Views: 5,021 |
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Haha, I can't believe it  Thanks Irene_I for this post and for lifting my mood. Keep up the good work. — Pass or fail! ElMaestro |
Ing. Helmut Schütz