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Pandu ★ India, 2009-02-23 15:00 (5712 d 20:37 ago) Posting: # 3281 Views: 12,275 |
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Dear All, Please give me the information about the chromatograms and how to select the chromatograms (20%) for submission of regulatory studies. Is there any SAS programme for selection of chromatograms. If aviable give me the information. Thanks and Regards, Pandu |
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Helmut ★★★   Vienna, Austria, 2009-02-23 16:36 (5712 d 19:01 ago) @ Pandu Posting: # 3282 Views: 11,085 |
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Dear Pandu, some regulators want to see the subjects already stated in the protocol. I don’t think that’s a good idea because analysts will try to produce especially ‘nice ones’. OK, subjects should be selected in a random manner – but IMHO after the analyses. You can set up anything in ![[image]](img/uploaded/image1.gif) , but why don’t you go for ‘true’ random numbers?— 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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Pandu ★ India, 2009-02-24 07:08 (5712 d 04:29 ago) (edited on 2009-02-24 11:14) @ Helmut Posting: # 3283 Views: 11,022 |
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Thanks for your reply. Protocol says that simply submission of 20% chromatograms. at present we given first 20% subjects data. As per your mention random.org. in that I want some clarifications. For example if sample size is 40. The 20% chromatograms are given that 8 subjects. As per random.com we select 8 time and taken that numbers. The clarifications are: 1. If subject number repeat. 2. If subject withdrawn form the study (Clinics). 3. If that subject samples asked for PK repeats. Is there is any program in SAS for selection of this 20% chromatograms. Thanks and Regards, Pandu -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Obinoscopy ★ USA, 2018-06-03 20:14 (2325 d 16:23 ago) @ Helmut Posting: # 18846 Views: 8,195 |
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Hi, Sorry for ressurecting an already thoroughly discussed topic. ❝ OK, subjects should be selected in a random manner – but IMHO after the analyses. ❝ You can set up anything in ❝ My question is this, which part of the guideline was it stated that the 20% Chromatogram has to be selected in a random fashion? Is the requirement for randomly selecting 20% Chromatogram in any Guideline? Regards, Edit: Merged with a later (deleted) post. Hint: You can edit your original post for 24 hours. [Helmut] — Scopy |
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ElMaestro ★★★ Denmark, 2018-06-03 21:16 (2325 d 15:21 ago) @ Obinoscopy Posting: # 18848 Views: 8,166 |
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Hi Obi, ❝ Is the requirement for randomly selecting 20% Chromatogram in any Guideline? It is in the guidelines to the same extent as the requirement for cherry-picking the 20%. Make sure to have an SOP which gives an objective way to select them. — Pass or fail! ElMaestro |
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Obinoscopy ★ USA, 2018-06-04 00:50 (2325 d 11:48 ago) @ ElMaestro Posting: # 18850 Views: 8,279 |
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Hi ElMaestro, Thanks for your response. ❝ It is in the guidelines to the same extent as the requirement for cherry-picking the 20%. Lol @ cherry-picking. But yeah, that should be a concern for the Sponsor or even the Regulator as the CRO site could cherry-pick runs of samples with wonderfully looking Chromatogram. However I noticed the FDA Guideline did state that chromatogram for NDAs and BLAs be randomly selected while chromatogram for ANDAs be serially selected. Which is great. I hope EMA considers this in subsequent reviews. ❝ Make sure to have an SOP which gives an objective way to select them. Yea, the draft FDA Guideline did state that. But it was not stated in the final FDA guideline.....strange. Regards, — Scopy |
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ElMaestro ★★★ Denmark, 2018-06-04 12:51 (2324 d 23:47 ago) @ Obinoscopy Posting: # 18852 Views: 8,091 |
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Hi Obi, ❝ ❝ Make sure to have an SOP which gives an objective way to select them. ❝ ❝ Yea, the draft FDA Guideline did state that. But it was not stated in the final FDA guideline.....strange. Isn't this to some extent to the wrong philosophy? Those chromatograms are an essential part of your submission, so of course the matter should be covered by an SOP, whether or not the need for an SOP is stated explicitly in the guidance. I see it that way.  — Pass or fail! ElMaestro |
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chiragkhatri ★ India, 2009-02-24 10:17 (5712 d 01:21 ago) @ Pandu Posting: # 3284 Views: 11,095 |
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Dear Pandu, Selection of 20% chromatograms is done by writing a simple code in SAS by input of the total number of volunteers in the study. This should be done prior to start of analysis to avoid bias. In this case bioanalytical dept can request the biostatistician to generate a random number, after the randomization is generated it will remain with biostatistician and shared with bioanalytical after the analysis is completed.This will also avoid bias. For eg the random number generated is 12, and you require 20% of 40 subjects, ideally you select 12-19 subjects serially, but if any subject is dropout inbetween then select next number e.g if 13 is dropout then select 12 and 14-20. If the random number itself is dropout then select next number ie from 13-20. if the random number is generated is last subject number then select for e.g 40 and 1-7. I hope its clear. Regards Chirag |
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Pandu ★ India, 2009-02-24 11:16 (5712 d 00:21 ago) @ chiragkhatri Posting: # 3285 Views: 10,933 |
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Dear Chirag Thanks for your information. As per your information, statistican will given one code (that is subject number) after that number we will take the subjects continuesly. But my clarificaion is that after that code we take continues subets (1-7 or 13-20). As per our bioanalytical department requires that total 20% subjects select at random (ex: 1,6,15,22,23,36,40,8 etc). Please give me the code how to generate this in SAS. Thanks and Regards Pandu |
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krish3108 ☆ 2009-03-03 10:10 (5705 d 01:27 ago) @ Pandu Posting: # 3305 Views: 10,845 |
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Dear Pandu, Normally the trend in industry is to submit those subjects in same QC run, and 20% of the number of subjects that have completed the study. Regards Krishnan -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Pandu ★ India, 2009-03-04 09:31 (5704 d 02:07 ago) @ krish3108 Posting: # 3312 Views: 10,828 |
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Dear Krishnan Thanks for your information. As per your information 20% of the number of subjects is selected and given in the report. My clarification is that how to select that 20% of subjects. (Please see my previous entry) Thanks and Regards, Pandu |
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d_labes ★★★ Berlin, Germany, 2009-03-04 13:15 (5703 d 22:22 ago) @ Pandu Posting: # 3313 Views: 10,847 |
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Dear Pandu, one very simple procedure:
No terrible software like "The power to know" needed, no criticism of bad 'pseudo' random number generators  .If you cannot avoid SAS I suggest you Gooooogle: SAS Simple Random Sample Without Replacement — Regards, Detlew |
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Helmut ★★★ Vienna, Austria, 2009-03-04 13:51 (5703 d 21:46 ago) @ d_labes Posting: # 3315 Views: 10,850 |
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Hi D. Labes! Great procedure, justified, well described, pointing out the crucial points, etc. But: ❝ […] leave this job to a nice looking young woman Although I like the idea and I’ve seen it in the recent past – when you have to defend your procedure I would suggest to stick to the ‘old fashioned way’! IMHO the drawing of lots should be done by an orphan (out from a bowl, not a hat). If you want to be very serious, you may use an urn instead of the hat. — 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, 2009-03-04 14:20 (5703 d 21:17 ago) @ Helmut Posting: # 3316 Views: 10,795 |
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Dear Helmut! ❝ IMHO the drawing of lots should be done by an orphan (out from a bowl, not a hat). If you want to be very serious, you may use an urn instead of the hat. Point 1: Orphan is a very good idea. But should be mandatory womanly. I have never seen a male "Lottofee" in Germany. But it may be that we run in an availability problem by requesting Orphans (see here for a percentage of available orphans on world). Point 2: I think a hat may be more available than a "Bowle", because alcohol is not allowed during work, at least here with me .Point 3: Urns are only good for the deads. — Regards, Detlew |
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ElMaestro ★★★ Denmark, 2009-03-05 21:43 (5702 d 13:54 ago) @ d_labes Posting: # 3327 Views: 10,870 |
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Dear d_labes, ❝ - Now drew 20% of the lots (or better leave this job to a nice looking young woman) I am terribly sorry but I personally have very bad experience with your suggested random number generator, and it stems in part from the fact that a typical NLYW is generally very much more unpredictable than Mersenne Twister* and her allies. In fact I have tried several times to interact with NLYWs but the result often is a general syntax error, occasionally also an access failure, and debugging does not seem to be an option. Therefore, I would strongly advise against your recommendation. Anyone who believes unpredictability is a desired property of a random number generator should thus think twice. EM. |
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d_labes ★★★ Berlin, Germany, 2009-03-06 11:02 (5702 d 00:35 ago) @ ElMaestro Posting: # 3330 Views: 10,855 |
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Dear ElMaestro, ❝ [...] I have tried several times to interact with NLYWs but the result often is a general syntax error, occasionally also an access failure, and debugging does not seem to be an option. Yes, yes  "Ein unergründlich Rätsel ist das Weib" (from the Opera "Mona Lisa" by Max von Schillings rough translation: woman is a inscrutable mystery) In case of syntax difficulties eventually the "Language of flowers"  is an option.But I think interacting with a NLYW is not an real option for Old Dogs (like me ). ![[image]](https://upload.wikimedia.org/wikipedia/commons/thumb/4/46/Nefertiti_30-01-2006.jpg/180px-Nefertiti_30-01-2006.jpg) In the context of the described random number generator the NLYW has only to interact with a hat and this is one of the best known interactions since long times (6.780.000!!! entries in Gooooogle picture search: "woman with hat").Nofretete, nicest looking ancient pharao woman, of course with a hat. — Regards, Detlew |
Ing. Helmut Schütz