mahendra ☆ US, 2013-10-24 18:10 (4056 d 04:30 ago) Posting: # 11753 Views: 40,461 |
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Hi I am working in analytical method development for Pharmaceutical company. I want to just learn how to do IVIVC comparison. For a Batch of drug product: for Invitro: data: % drug dissolved in 15 min, 30 min, 45 min intervals. For invivo: What data do i need ? Like AUC, Cmax etc. I am unbale to see examples on this. Colud any one help me to learn this? Its my interest. I have Minitab 16: is it capble to IVIVC? I see recently in a post that mentioned IVIVC is possible in R software? I dont know about R software and i have not used it? Is it simple to run IVIVC in R to learn? I want to see practically how IVIVC data give the information for next development? Thanks in advance |
yjlee168 ★★★ Kaohsiung, Taiwan, 2013-10-24 21:22 (4056 d 01:18 ago) @ mahendra Posting: # 11758 Views: 37,616 |
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Hi again, Search this forum first (tons of previous discussion about this topic in this Forum) and then ask master Google if necessary. ❝ I am working in analytical method development for Pharmaceutical company. ❝ ❝ I want to just learn how to do IVIVC comparison. ❝ ❝ For a Batch of drug product: ❝ ❝ for Invitro: data: % drug dissolved in 15 min, 30 min, 45 min intervals. You will need dissolution profile data for 3-6 solid dosage forms with different release rates. More is better. Leave one solid dosage form for external validation if you like to do so. Otherwise, you can use internal validation with all solid dosage forms. Your planned sampling time (15 min, 30 min and 45 min) should be more. Don't forget that these are all MR (not IR) dosage forms. ❝ For invivo: What data do i need ? Like AUC, Cmax etc. for kel (not ka!) estimation: dose iv/solution/suspension (one of these) dosage forms to estimate ka for each subject. for ivivc model: to dose previously mentioned solid dosage forms of various release rates to each subject. ❝ I have Minitab 16: is it capble to IVIVC? It should be able to do the job. Very nice stat computer program. But I don't have any experience with it. ❝ I see recently in a post that mentioned IVIVC is possible in R software? Yes, you can browse CRAN near you and look at (and search) the packages. There are Rivivc and ivivc. Pick what you need. ❝ I dont know about R software and ihave not used it? Is it simple to run IVIVC in R to learn? Of course, it is very simple for a pharmaceutical scientist. UseR! ❝ I want to see practically how IVIVC data give the information for next development? I don't quite get your point here. Sorry about that. — All the best, -- Yung-jin Lee bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
mahendra ☆ US, 2013-10-24 21:45 (4056 d 00:54 ago) @ yjlee168 Posting: # 11759 Views: 37,538 |
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Hi yjlee168 Thank you very much ❝ ❝ I want to see practically how IVIVC data give the information for next development? ❝ ❝ I don't quite get your point here. Sorry about that. Could you plz develop an example with hypothetical data for invivo and invitro for an IR, MR formulation and analysis in excel. Mahendra |
yjlee168 ★★★ Kaohsiung, Taiwan, 2013-10-25 00:21 (4055 d 22:18 ago) @ mahendra Posting: # 11760 Views: 37,630 |
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Dear Mahendra, If you really like to use excel, you can ask Gohel M, et. al. [quoted from their website] ... A copy of EXCEL worksheet can be obtained from the authors upon request... The following simulated data are obtained from ivivc package. pk original data (dose = 100)for estimate 'kel' (as well as 'ka' and 'Vd') are The in-vivo (conc. obs) and in-vitro (FRD, cumulative release fraction (%)) data vs. time with two different pH (1.2 & 6.8) media are
pH formula subject time conc.obs FRD where S: slow release; M: median release, F: fast release These are just simulated data. You may need more subjects for in-vivo test and/or more pH and add more dosage forms with different release rates (such as "very slow", "very fast") for in-vitro test. I don't know if this is what you need or not. Please consult with official guidelines/guidance for more details in study design of ivivc. That's very mandatory. The information here is very, very brief! If you have budget, you can also consider the commercial computer program- IVIVC TOOLKIT from CERTARA (used to be Pharsight?). ❝ Could you plz develop an example with hypothetical data for invivo and invitro for an IR, MR formulation and analysis in excel. — All the best, -- Yung-jin Lee bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
Helmut ★★★ Vienna, Austria, 2013-10-25 16:38 (4055 d 06:01 ago) @ yjlee168 Posting: # 11766 Views: 37,439 |
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Hi Yung-jin, ❝ […] the commercial computer program- IVIVC TOOLKIT from CERTARA (used to be Pharsight?). Pharsight was acquired by Tripos (itself belonging to Certara) some years ago. Now the official name is “Pharsight, a Certara Company”. — 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 |
mahendra ☆ US, 2013-10-25 18:49 (4055 d 03:50 ago) @ yjlee168 Posting: # 11773 Views: 36,944 |
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Hi yjlee Thankyou very much. |
yjlee168 ★★★ Kaohsiung, Taiwan, 2013-10-27 06:41 (4053 d 14:58 ago) @ mahendra Posting: # 11779 Views: 37,323 |
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Hi mahendra, One more choice for ivivc that I almost forget: PCDCON if you like to take a look. You can download it from this Forum (here). It's freeware too. It can do numerical convolution/deconvolution. Please note that it is a 16-bit DOS computer program written with FORTRAN-77. However, you can run it on a 32-bit Windows OS under DOS command line mode. It will fail on a x64 Windows OS. Hope this can help. — All the best, -- Yung-jin Lee bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
thalita_m ☆ Brazil, 2019-06-18 04:51 (1993 d 17:49 ago) @ yjlee168 Posting: # 20331 Views: 18,422 |
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❝ If you really like to use excel, you can ask Gohel M, et. al. [quoted from their website] Hi Mr. Yung-jin Lee, You recommend me this article! I request the Excel worksheet but the authors did not answer to my request. Did you have this worksheet ? Thank you. Thalita |
jag009 ★★★ NJ, 2013-10-25 01:17 (4055 d 21:22 ago) @ mahendra Posting: # 11762 Views: 37,543 |
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Hi, ❝ I want to just learn how to do IVIVC comparison. I suggest you to go to pubmed and search for articles on IVIVC. There are a number of them. (Yes the articles exist) You need to understand the background first. Diving straight into R with not help you and would probably end up with more fustrations... ❝ I have Minitab 16: is it capble to IVIVC? No. John |
Helmut ★★★ Vienna, Austria, 2013-10-25 16:43 (4055 d 05:56 ago) @ jag009 Posting: # 11767 Views: 37,720 |
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Hi John, ❝ ❝ I have Minitab 16: is it capble to IVIVC? ❝ ❝ No. “Out of the box”: No. But it would be possible to code IVIVC in it – like in any other statistical software. If you know the formulas and have a lot of time even paper/pencil/brain would do the job. — 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 |
jag009 ★★★ NJ, 2013-10-25 18:27 (4055 d 04:12 ago) @ Helmut Posting: # 11770 Views: 37,393 |
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Hi Helmut, ❝ “Out of the box”: No. But it would be possible to code IVIVC in it – like in any other statistical software. If you know the formulas and have a lot of time even paper/pencil/brain would do the job. Amount of time needed = infinity? Heck you might as well do it in Excel (don't laugh, there are papers out there for IVIVC in excel. Langenbucher wrote a few papers on this). Jon |
Helmut ★★★ Vienna, Austria, 2013-10-25 18:38 (4055 d 04:01 ago) @ jag009 Posting: # 11771 Views: 37,089 |
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Hi John, ❝ Amount of time needed = infinity? ≠ ∞, but very long. Errors likely. I would suggest to perform the calculations at least twice. ❝ Heck you might as well do it in Excel (don't laugh, there are papers out there for IVIVC in excel. Langenbucher wrote a few papers on this). I know. I got one Excel-sheet from Jean-Michel Cardot (who worked together with Frieder Langenbucher in Basel). He uses it in his workshops but always switches to the cell-formulas in order to show how nasty that is. It is too easy to screw up the cell-references when adding rows/columns… BTW, he also has set up IVIVC in SAS. Not an easy task as well. By far less error-prone, but still a lot of code. — 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 |
jag009 ★★★ NJ, 2013-10-28 21:42 (4051 d 23:57 ago) @ Helmut Posting: # 11800 Views: 36,677 |
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Hi Helmut, ❝ I know. I got one Excel-sheet from Jean-Michel Cardot (who worked together with Frieder Langenbucher in Basel). He uses it in his workshops but always switches to the cell-formulas in order to show how nasty that is. It is too easy to screw up the cell-references when adding rows/columns… BTW, he also has set up IVIVC in SAS. Not an easy task as well. By far less error-prone, but still a lot of code. Actually I followed Langenbucher's papers and drafted up the excel spreadsheet myself. I used data from an older IVIVC study report, fooled around with my newly made excel spreadsheet, and it worked perfectly! (Granted that during the spreadsheet development my boss complained about my verbal use of explicit english vocabularies) . John |
luvblooms ★★ India, 2013-10-29 06:08 (4051 d 15:32 ago) @ jag009 Posting: # 11801 Views: 36,699 |
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Dear John!!! ❝ Actually I followed Langenbucher's papers and drafted up the excel spreadsheet myself. I used data from an older IVIVC study report, fooled around with my newly made excel spreadsheet, and it worked perfectly! I tried to follow Langenbucher's paper and was able to make some examples what he mentioned in Paper I and II but failed miserably when I tried his paper no III and IV (mainy the convolution part). Looks like I got a teacher . Any id for direct message? Regards Luv — ~A happy Soul~ |
jag009 ★★★ NJ, 2013-10-29 16:07 (4051 d 05:32 ago) @ luvblooms Posting: # 11804 Views: 36,600 |
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Hi Luvbloom, Where did you get stuck specifically? I ran the exercise myself about 4-5 yrs ago because we wanted to make a IVIVC program (with my former post-doc friend) for internal use so I don't remember the full details (need to think back...). Did you take into account the time scaling? John |
luvblooms ★★ India, 2013-10-30 08:00 (4050 d 13:39 ago) @ jag009 Posting: # 11810 Views: 36,841 |
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Hi John ❝ Where did you get stuck specifically? I got stuck in the the third paper "Handling of computational in vitro/in vivo correlation problems by Microsoft Excel: III. Convolution and deconvolution" specially with the system analysis and functional convolution ❝ I ran the exercise myself about 4-5 yrs ago because we wanted to make a IVIVC program (with my former post-doc friend) for internal use so I don't remember the full details (need to think back...). Maths and I have never exactly been best friends I guess ❝ Did you take into account the time scaling? I was trying to mimic the example given in the paper but no avail!!! I have prepared my open VB based spread sheet where it take cares of Time scaling and all but still not able to work on convolution for prediction purpose. I have started working on it again just to make sure I have not forgot the basics. P.S: If you get time do read this BIOEQUIVALENCE STUDY OF OMEPRAZOLE CAPSULE: IN VITRO IN VIVO Regards — ~A happy Soul~ |
Helmut ★★★ Vienna, Austria, 2013-10-30 15:40 (4050 d 05:59 ago) @ luvblooms Posting: # 11816 Views: 36,594 |
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Hi Luv, ❝ If you get time do read this BIOEQUIVALENCE STUDY OF OMEPRAZOLE CAPSULE: IN VITRO IN VIVO → Service Unavailable From ’s cache I gather it is Somnath Sakore and Bhaswat Chakraborty International Journal of Universal Pharmacy and Life Sciences 2(1): January-February 2012, 37–47 Unfortunately I don’t find the paper in the journal’s archive. — 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 |
jag009 ★★★ NJ, 2013-10-30 17:35 (4050 d 04:04 ago) (edited on 2013-10-30 19:21) @ luvblooms Posting: # 11821 Views: 36,473 |
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Hi Luvbloom, Can you post the data that you obtain from the article so I can goof around? (see if you can get an abstract posted here as well) I don't have access to that article. John |
luvblooms ★★ India, 2013-10-31 09:15 (4049 d 12:24 ago) @ jag009 Posting: # 11834 Views: 36,297 |
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Hey John and Helmut ❝ I don't have access to that article. ❝ Unfortunately I don’t find the paper in the journal’s archive. Looks like it has been removed or something. I had some serious doubt on the methods mentiod in the paper and I wrote to the author as well but all mails bounced back. And the major concern was on two points
Let me check if I can get it in my database. Regards — ~A happy Soul~ |
jag009 ★★★ NJ, 2013-10-31 21:31 (4049 d 00:09 ago) @ luvblooms Posting: # 11848 Views: 36,391 |
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Hi Luvbloom, I know one of the authors (the 2nd one). We worked together before. Maybe I can catch him via email. Anyhow, let me know if you have access in your database. I recall seeing a paper on Omeprazole IVIVC but I can't find it. John |
jag009 ★★★ NJ, 2013-11-06 17:44 (4043 d 03:56 ago) @ luvblooms Posting: # 11864 Views: 36,173 |
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Hi Luvbloom, ❝ Looks like it has been removed or something. ❝ I had some serious doubt on the methods mentiod in the paper and I wrote to the author as well but all mails bounced back. ❝ And the major concern was on two points
❝ Let me check if I can get it in my database. Any news on the paper? Now you got me interested again Thanks John |
luvblooms ★★ India, 2013-11-07 11:50 (4042 d 09:50 ago) @ jag009 Posting: # 11865 Views: 36,274 |
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Hi John Got the paper!! But where to share? Regards — ~A happy Soul~ |
jag009 ★★★ NJ, 2013-11-27 17:44 (4022 d 03:56 ago) @ luvblooms Posting: # 11982 Views: 35,929 |
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Hi Luvbloom, Take a look at Certara's SIMCYP website. They have a poster on IVIVC based on PBPK modelling, quite interesting. The poster only have limited info though. John |
luvblooms ★★ India, 2013-11-27 20:31 (4022 d 01:08 ago) @ jag009 Posting: # 11983 Views: 35,842 |
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— ~A happy Soul~ |
jag009 ★★★ NJ, 2013-11-27 21:04 (4022 d 00:36 ago) @ luvblooms Posting: # 11985 Views: 35,859 |
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Hi Luvbloom, ❝ Or something different? Yes the 2nd one. I was at AAPS but didn't really get a chance to talk to the presenter but I sort of have an idea. I would like to see them apply it to other BCS classes though (maybe not 3 and 4)... John |
jag009 ★★★ NJ, 2013-11-28 07:01 (4021 d 14:39 ago) @ luvblooms Posting: # 11986 Views: 35,953 |
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Hi Luvbloom, ❝ Got the paper!! ❝ But where to share? Check your personal email. I sent a message to you. You can email me the paper. Thanks John |
Helmut ★★★ Vienna, Austria, 2013-11-07 15:50 (4042 d 05:49 ago) @ jag009 Posting: # 11866 Views: 36,124 |
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Hi John, ❝ Any news on the paper? Now you got me interested again You may contact Luv by means of the secure web-form. Just click here. There you can give your e-mail address & he might contact you directly. — 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 |
jag009 ★★★ NJ, 2013-11-27 17:42 (4022 d 03:57 ago) @ Helmut Posting: # 11981 Views: 35,784 |
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Thanks Helmut. John |
thalita_m ☆ Brazil, 2019-06-18 04:46 (1993 d 17:53 ago) @ jag009 Posting: # 20330 Views: 18,286 |
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❝ ❝ I got one Excel-sheet from Jean-Michel Cardot… ❝ ❝ Actually I followed Langenbucher's papers and drafted up the excel spreadsheet myself… Hi John, First, sorry to resuscitate this post. Second, could you please send me the Excel-sheet from Mr. Cardot? Or just an example of it? Thanks for your help. Thalita Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Helmut ★★★ Vienna, Austria, 2019-06-18 13:08 (1993 d 09:32 ago) @ thalita_m Posting: # 20332 Views: 18,072 |
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Hi Thalita, THX for editing your personal profile! That’s a rarity. Instead of playing Chinese whispers please contact Jean-Michel (j-michel.cardotuca.fr) directly. — 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 |
thalita_m ☆ Brazil, 2019-06-21 00:18 (1990 d 22:21 ago) @ Helmut Posting: # 20351 Views: 18,122 |
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❝ Instead of playing Chinese whispers please contact Jean-Michel (j-michel.cardotuca.fr) directly. Hi Helmut, Thanks for the contact. I text Mr. Cardot and just got te Excel sheets. Thank you very much! |
Abel1972 ☆ Philippines, 2020-06-17 07:28 (1628 d 15:12 ago) @ thalita_m Posting: # 21546 Views: 13,081 |
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Hi Thalita_m, I'm a beginner in IVIVC and currently doing some readings on the topic. I emailed Mr. Cardot for the files, but apparently the university is closed due to COVID-19. If you currently have access to the Excel files, I am hoping you could share it to me so I could better understand the calculations used. Thanks in advance. Abel |
thalita_m ☆ Brazil, 2022-09-17 07:50 (806 d 14:50 ago) @ Abel1972 Posting: # 23304 Views: 5,871 |
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Hi Abel! ❝ I'm a beginner in IVIVC and currently doing some readings on the topic. I emailed Mr. Cardot for the files, but apparently the university is closed due to COVID-19. If you currently have access to the Excel files, I am hoping you could share it to me so I could better understand the calculations used. Thanks in advance. I hope it was not too late to send you the files, but I was absent from the forum updates! I really sorry for that. Please, if you still want the Excel files, email me: [email protected] See you! |
Achievwin ★★ US, 2020-06-17 17:00 (1628 d 05:39 ago) @ Helmut Posting: # 21548 Views: 13,189 |
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❝ Out of the box […] and have a lot of time even brain […] would do the job. Oh R we still using it? - AW |
mahendra ☆ US, 2013-10-25 18:48 (4055 d 03:52 ago) @ jag009 Posting: # 11772 Views: 36,922 |
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Hi John Thanks |
vinayshed ☆ 2013-10-28 09:54 (4052 d 11:45 ago) @ mahendra Posting: # 11789 Views: 36,758 |
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Mahendra If you really want to understand how to carry out IVIVC, you have to know the basics of it and it can be carried out using Excel. You have to have dissolution data and plasma time vs concn. data. Once you understand the procedure, then you can use any software. Jean Michel Cardot's Excel sheets are good and easy to understand. |