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ashwinim13 ☆ India, 2008-12-16 14:15 (5992 d 07:54 ago) Posting: # 2930 Views: 21,819 |
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Dear all I would like to know the how do we find out outlier in Bioequivalence studies with the Lund's Test. What will be the SAS Code. Thanks to everybody in advance... With kind regards |
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atish_azad ☆ 2008-12-17 07:22 (5991 d 14:48 ago) @ ashwinim13 Posting: # 2931 Views: 20,297 |
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Dear Ashwinim 13, Kindly refer book on Pharmaceutical Statistic practical and clinical application by Sanford Bolton for outlier detection by Lunds method. Hope this will help. Regards, Atish |
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ashwinim13 ☆ India, 2008-12-17 10:31 (5991 d 11:38 ago) @ atish_azad Posting: # 2932 Views: 20,097 |
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Dear Atish, Thanks for your prompt response. I have checked Pharmaceutical Statistic practical and clinical application by Sanford Bolton for outlier detection at page no 308, code is mentioned but my doubt is at page no 309 it is written "This model has 12 parameters & 36 observations. Could you please explain this. Thanks in advance Regards Ashwinim 13 -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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d_labes ★★★ Berlin, Germany, 2008-12-17 10:33 (5991 d 11:37 ago) @ ashwinim13 Posting: # 2933 Views: 20,609 |
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Dear Ashwinim13, see Helmut's post here for the applicability of Lund's test. You will recognize that Lund's test is outdated in BE studies. BTW: Search, search and once again search. Hint: Search box is in the upper right corner  .— Regards, Detlew |
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statistician ☆ India, 2010-05-25 13:07 (5467 d 10:02 ago) @ ashwinim13 Posting: # 5372 Views: 19,701 |
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dear friends i am new to this forum i would like to know about the use of grubbs test in ba/be studies when to use it and i need sas grubbs outlier detection program for 2x2 cross over design. i will be thankfull if anyone clear my doubts. thank you, RK |
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Helmut ★★★   Vienna, Austria, 2010-05-28 14:10 (5464 d 08:59 ago) @ statistician Posting: # 5393 Views: 19,554 |
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Dear RK, ❝ i would like to know about the use of grubbs test in ba/be studies when to ❝ use it  I would not recommend it... There are better alternatives.Have a look at the Outliers category and Search… ❝ and i need sas grubbs outlier detection program for 2x2 cross over design.  — 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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KR ★ India, 2010-05-31 17:18 (5461 d 05:52 ago) @ Helmut Posting: # 5404 Views: 19,722 |
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Dear HS, I would like to know why u r not recommending the Grubbs' outlier test in bioequivalence? If this test is not strong enough then which is the better outlier test for bioequivalence study? Can we use Lund's outlier test instead of Grubbs' test as a better option? Thanks in advance, KR Edit: Full quote removed. Please see this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2010-05-31 19:59 (5461 d 03:11 ago) @ KR Posting: # 5406 Views: 19,184 |
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Dear KR, please don’t quote the entire text of the previous post all the time (read this post). We (the team of moderators) had to edit all (!!) of your previous posts... Using the ![[image]](screenshots/InstrPst3.png) would have displayed the mess. See also here. You may ![[image]](img/edit.png) Edit your post within 24 hours after posting – no need to open a new one (which I deleted this time).Maybe it’s high time to read the forum’s policy. — 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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Helmut ★★★ Vienna, Austria, 2010-06-08 17:15 (5453 d 05:54 ago) @ KR Posting: # 5474 Views: 19,729 |
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Dear KR and all, at last week’s EGA workshop one of the issues was following statement (Section 4.1.10) of the BE-GL For the acceptance interval to be widened the bioequivalence study must be of a replicate design where it has been demonstrated that the within-subject variability for Cmax of the reference compound in the study is >30%. The applicant should justify that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers. No clarification is given in the presentations, but EMA’s panellists agreed that
 nonparametric by nature!). Keywords: lower/upper adjacent values, inner and outer fence,… Most people would treat values outside the lower/upper quartile ±3× the interquartile range (IQR) as severe outliers (and ±1.5× IQR as mild outliers), but even the method of calculating the quartiles and IQR is not unambigous.  — 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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d_labes ★★★ Berlin, Germany, 2010-06-15 13:48 (5446 d 09:22 ago) @ Helmut Posting: # 5512 Views: 19,129 |
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Dear Helmut, seems to me that this meeting was overshadowed by high statistical skills.  SCRN. — Regards, Detlew |
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Dr_Dan ★★ Germany, 2010-06-15 14:36 (5446 d 08:34 ago) @ Helmut Posting: # 5513 Views: 19,304 |
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Dear Helmut and all At the EGA workshop you mentioned Lorelei Lutter pointed out the contradiction in the guideline: On the one hand no outlier test is accepted in order to evaluate the results of a BE study and on the other hand it should be demonstrated that the high within-subject variability in a replicate study is not the result of outliers. The whole problem with outliers is not solved by the regulatory authorities and they refuse to discuss this. Why should I detect outliers if no outlier test is accepted and the whole dataset should be evaluated? I suggest not to perform any outlier test. I am looking forward to further comments regarding this topic. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★ Vienna, Austria, 2010-06-15 14:56 (5446 d 08:13 ago) @ Dr_Dan Posting: # 5515 Views: 19,480 |
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Dear Dan & all! ❝ […] Lorelei Lutter pointed out the contradiction in the guideline: Lorelei comes from Canada, where statistical outlier tests are recommended in the current drafted guideline – THX to Eric Ormsby! If you want to follow EMA’s GL literally you have to act like a schizophrenic:
— 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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d_labes ★★★ Berlin, Germany, 2010-06-15 17:40 (5446 d 05:30 ago) @ Helmut Posting: # 5517 Views: 19,108 |
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Dear Dan & dear Helmut! Was there any POV what to do if there are outliers, how ever identified? — Regards, Detlew |
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Helmut ★★★ Vienna, Austria, 2010-06-15 17:59 (5446 d 05:10 ago) @ d_labes Posting: # 5518 Views: 19,342 |
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Dear D. Labes! ❝ Was there any POV what to do if there are outliers, how ever identified? Easy. In a conventional BE study you define something in the protocol – subjects may be removed before any statistical procedure takes place (e.g., subject vomits, diarrhea). Once you decided the data-set is ready to be handled to the statistician, no statistical tests whatsoever. You may eye-ball strange results, but no way to remove a subject from the analysis. In a replicate design where you want to go with ABEL, you have to demonstrate that the CV is not caused by outliers – again eye-balling (aka box plots). Regulators are a strange bunch. Gerald Beuerle (ratiopharm) presented an example, where due to a sample mix-up in the area of Cmax the test would pass BE, which otherwise (either after exchange of values or after removal of the subject) would fail. Even then panellist stated that this is not acceptable. Sancta simplicitas! Kersti Oselin (MHRA) went one step further and stated, that one can expect such events and should power the study to be protected against that.  — 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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d_labes ★★★ Berlin, Germany, 2010-06-15 18:14 (5446 d 04:55 ago) @ Helmut Posting: # 5521 Views: 19,044 |
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Dear Helmut! ❝ In a replicate design where you want to go with ABEL, you have to demonstrate that the CV is not caused by outliers – again eye-balling (aka box plots). Boxplots of intra-individual contrasts R-R? Or what else (Mixed model further not acceptable)? Ok, now it happens that I have an/some outlier(s). Or some assessor does not follow my arguing that I have none. What then? Scaling not allowed? — Regards, Detlew |
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Helmut ★★★ Vienna, Austria, 2010-06-15 18:29 (5446 d 04:40 ago) @ d_labes Posting: # 5523 Views: 19,083 |
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Dear D. Labes! ❝ Boxplots of intra-individual contrasts R-R? No idea; but I would say that’s reasonable. ❝ Or what else (Mixed model further not acceptable)? Nice question. Next question. ❝ Ok, now it happens that I have an/some outlier(s). Or some assessor does not follow my arguing that I have none. What then? Scaling not allowed? Right guess. It’s a nightmare. — 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