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ElMaestro ★★★ Denmark, 2015-06-03 19:57 (3610 d 01:04 ago) Posting: # 14905 Views: 10,181 |
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Hi all, "BSWP response to letter received from Dr Fuglsang regarding Kinetica software used in BE studies (EMA/1085 07/2015). The CHMP discussed the BSWP response and concluded that no medically relevant impact could be observed following the assessed studies. The Committee agreed that a response to CMDh should be drafted by BSWP as well as a response letter to Dr Fuglsang." I tried to read the sentence a few times but I am not convinced I understand what they are actually saying. If I get it right there is no problem. I can live with that as I am not on a personal crusade against anything or anyone. Haha I am just a scientist and not even a good one at that. Most of us have been involved in handling of narrowly failing drugs. The acceptance range 80.00%-125.00% is very strictly enforced. Two decimals. And that's it. I am under the impression that the error introduced by Kinetica on the PE can be somewhat higher than that zero tolerance regulators enforce. Is that not a little strange? Perhaps I should just put this entire story into the odd sock drawer and consider it another curiosum which I can't fathom much like Conchita Wurst, the Danish soccer championsship in 1992, or the reason why anyone would wish to put raisins or cornflakes inside RitterSport? Edit: Category changed. [Helmut] — Pass or fail! ElMaestro |
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d_labes ★★★ Berlin, Germany, 2015-06-03 21:03 (3609 d 23:59 ago) @ ElMaestro Posting: # 14906 Views: 8,740 |
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Öberster großer Meister! We know already the (published) opinion of some well known member of the PKWP. Seems statisticians of the EMA (BSWP) are adepts of his opinion. I'm curious why. Scientifically! It's a pitty that we don't know a counter example. In my gut feeling there must be some! Remenber our discussion that Kinetica is Number three? Any body out there used Kinetica in unbalanced studies? I promise you full anonymity  .ElMaestro: Let us be informed if you could identify some "Why's". Scientifically! Some insight from Helmut's presentation in Prague? — Regards, Detlew |
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ElMaestro ★★★ Denmark, 2015-06-03 22:15 (3609 d 22:47 ago) @ d_labes Posting: # 14909 Views: 8,743 |
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Hi again, ❝ It's a pitty that we don't know a counter example. ❝ In my gut feeling there must be some! Remenber our discussion that Kinetica is Number three? There are tons of studies evaluated with Kinetica. Usually CROs write that stuff on their homepage. But with the publications by the Dynamic Trio CROs seem to be less enthusiastic about mentioning Kinetica. And it does take some time to decide to buy another package. ❝ Any body out there used Kinetica in unbalanced studies? I promise you full anonymity Difficult for a CRO to come forward possibly? But Sponsors might if they had failed studies that could be potentially passing?! Remains to be seen. Couldn't it be simulated? I think we know the equations used normally and by TFS. We could simulate some scenarios and count the frequency by which the wrong decision is taken. I could write this stuff in a few days. You could probably do it quicker. But I have no good idea on how to use the result? ❝ ElMaestro: Let us be informed if you could identify some "Why's". Scientifically! I like the idea but must admit I simply don't know how to get answers to those why's. I feel I am not well-connected to the extent that I can ask. ❝ Some insight from Helmut's presentation in Prague? Helmut's talk was about validation and served as great inspiration. It did not touch so much on Kinetica but contained a wealth of other info. While we are at it: When I audit CROs I often ask if they rely on automated IQ/OP/PQ. They usually say they validate formally with a plan and approvals and signatures and coffee and cake and IQ/OQ/PQ scripts. When I ask them if they have checked if some of those scripts contain anything relevant to BE the answer is no. Always. You can look up in ICH E6 that software must perform for the intended purpose (clause 5.5.3.) If you buy a pair of shoes you check that they fit your feet, right? — Pass or fail! ElMaestro |
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Helmut ★★★   Vienna, Austria, 2015-06-04 03:07 (3609 d 17:54 ago) @ ElMaestro Posting: # 14911 Views: 8,923 |
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Dear both, seems that you are having fun! ❝ ❝ In my gut feeling there must be some! Remenber our discussion that Kinetica is Number three? Since Kinetica is widely-used in the Middle East I’m in contact with regulators from Saudi Arabia and Oman, who are exploring the issue since last October. They confirmed the defect immediately. From the information given in the “Thermo Scientific Informatics Support Resource Center” (see this post) I seriously suspected that only the crossover defect was corrected (our second paper was not mentioned). Ten days ago I got a response from statisticians of the SFDA (THX!). They compared our reference data sets in Phoenix 6.3 to the new “Service Release 1” of Kinetica 5.1 (of Dec 24, 2014). Bingo! ❝ You can look up in ICH E6 that software must perform for the intended purpose (clause 5.5.3.) Don’t forget Annex III to Procedure for Conducting GCP Inspections requested by the EMEA: Computer Systems (2007), which is a one-pager leading to the very exhaustive PIC/S Guidance: Good Practices for Computerised Systems in Regulated “GXP” Environments (2007) — 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 |
![[image]](img/uploaded/image4.gif)
Of course, the test for sequence effects in crossovers (|
nobody nothing 2015-06-03 21:26 (3609 d 23:35 ago) @ ElMaestro Posting: # 14907 Views: 8,771 |
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Ritter Sport Knusper and Traube Nuss are my absolute favourites! Besides this here, so so sad, but so so true... https://www.youtube.com/watch?v=9FnO3igOkOk ...at least Mr. Blatter has quit — Kindest regards, nobody |
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d_labes ★★★ Berlin, Germany, 2015-06-03 22:06 (3609 d 22:55 ago) @ nobody Posting: # 14908 Views: 8,629 |
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❝ ...at least Mr. Blatter has quit And nobody is there to muck out ... — Regards, Detlew |
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ElMaestro ★★★ Denmark, 2015-06-03 22:16 (3609 d 22:45 ago) @ nobody Posting: # 14910 Views: 8,687 |
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Dear nobody, ❝ Ritter Sport Knusper and Traube Nuss are my absolute favourites! I am seriously beginning to have doubts about your sanity.  — Pass or fail! ElMaestro |
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nobody nothing 2015-06-04 10:01 (3609 d 11:00 ago) @ ElMaestro Posting: # 14912 Views: 8,546 |
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Just to relpy to the Austrian-Saudi perspective: EU documents often start to make sense when you replace "medical" by "political"... — Kindest regards, nobody |
Ing. Helmut Schütz