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Hello,
I have a basic question in IVIVC
I have a drug's dissolution data collcted at certain time points and I also have Invivo plasma
concentrations measured at different time points to that of dissolution time points.
If i have to build IVIVC i know i have to perform Time scaling, Can anyone explain me how to do
timescaling
Regards
Kaushik
[You might look at: LEVY, G., Leonards, J., & Procknal, J. (1965). Developement of in vitro
dissolution tests which correlate quantitatively with dissolution rate limited drug absorption in
man. Journal of Pharmaceutical Sciences, 54(12)(12), 1719–1722. doi:10.1002/jps.2600541204 - db]
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Hi Kaushik,
Conceptually this is not very difficult. You fit some function f(t) to
the dissolution curve, and then look for the function F(f(a0+a1*t)) that
would describe in-vivo dissolution (a0 is delay, a1 is the time scale).
Implementation could be tricky. WinNonlin has it implemented as add-on,
as well as GastroPlus. Or you can do it in Nonmem (or other modeling
software), see
A comparison of the prediction accuracy of two IVIVC modelling
techniques Clare Gaynor, Adrian Dunne, John Davis DOI: 10.1002/jps.21220
or other works by Adrian Dunne and co-authors
Leonid
--
Leonid Gibiansky, Ph.D.
QuantPharm LLC
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