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RegisterIVIVC calculations [Dissolution / BCS / IVIVC]
posted by yjlee168 
– Kaohsiung, Taiwan, 2013-10-24 21:22 (4064 d 21:38 ago) – Posting: # 11758
Views: 37,643
Hi again,
Search this forum first (tons of previous discussion about this topic in this Forum) and then ask master Google if necessary.
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 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.
It should be able to do the job. Very nice stat computer program. But I don't have any experience with it.
Yes, you can browse CRAN near you and look at (and search) the packages. There are Rivivc and ivivc. Pick what you need.
Of course, it is very simple for a pharmaceutical scientist. UseR!
I don't quite get your point here. Sorry about that.
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
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
Complete thread:
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- Minitab etc. jag009 2013-10-25 16:27
- XL Helmut 2013-10-25 16:38
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- Good News jag009 2013-11-28 06:01
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- Contact Helmut 2013-11-07 14:50
- Contact jag009 2013-11-27 16:42
- Good News luvblooms 2013-11-07 10:50
- XL luvblooms 2013-10-31 08:15
- XL luvblooms 2013-10-30 07:00
- XL jag009 2013-10-29 15:07
- XL thalita_m 2019-06-18 02:46
- Jean-Michel Helmut 2019-06-18 11:08
- Jean-Michel thalita_m 2019-06-20 22:18
- Jean-Michel Abel1972 2020-06-17 05:28
- Jean-Michel thalita_m 2022-09-17 05:50
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- Jean-Michel thalita_m 2019-06-20 22:18
- Jean-Michel Helmut 2019-06-18 11:08
- XL luvblooms 2013-10-29 05:08
- XL jag009 2013-10-28 20:42
- XL Helmut 2013-10-25 16:38
- Minitab etc. Achievwin 2020-06-17 15:00
- Minitab etc. jag009 2013-10-25 16:27
- IVIVC calculations mahendra 2013-10-25 16:48
- Minitab etc. Helmut 2013-10-25 14:43
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Ing. Helmut Schütz