IVIVC calculations [Dissolution / BCS / IVIVC]

posted by yjlee168 Homepage – Kaohsiung, Taiwan, 2013-10-24 19:22 (2554 d 01:12 ago) – Posting: # 11758
Views: 28,458

(edited by yjlee168 on 2013-10-24 19:53)

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?

:confused: I don't quite get your point here. Sorry about that.

All the best,
-- Yung-jin Lee
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Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
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