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RegisterIVIVC with literature IV/IR data to serve as impulse func. [Regulatives / Guidelines]
Thank you Jean-Michel,
Questions:
1) I agree with most of what you said. Correct me on this.. --> Since the UIR (Unit impulse function) only serves as a "Denominator" for the IVIVC process for the convolution and deconvolution steps, if one keeps it constant throughout the IVIVC modelling process (and later stages) then shouldn't it be okay if literature IR or IV data is used?
2) There is a chapter in the IVIVC book edited by David Young et al. Bill Gullesbie wrote a chapter (2.3) on "Method Not Requiring an IV or IR Reference Dose". He suggested that the UIR can be estimated by fitting the overall convolution model to the plasma concentrations resulting from the ER dosage forms.
John
Edit: Dear John, please avoid typewiter-style multiple blanks in future posts. They are not displayed anyway. [Helmut]
Questions:
1) I agree with most of what you said. Correct me on this.. --> Since the UIR (Unit impulse function) only serves as a "Denominator" for the IVIVC process for the convolution and deconvolution steps, if one keeps it constant throughout the IVIVC modelling process (and later stages) then shouldn't it be okay if literature IR or IV data is used?
2) There is a chapter in the IVIVC book edited by David Young et al. Bill Gullesbie wrote a chapter (2.3) on "Method Not Requiring an IV or IR Reference Dose". He suggested that the UIR can be estimated by fitting the overall convolution model to the plasma concentrations resulting from the ER dosage forms.
John
Edit: Dear John, please avoid typewiter-style multiple blanks in future posts. They are not displayed anyway. [Helmut]
Complete thread:
- IVIVC with literature IV/IR data to serve as impulse func. jag009 2012-07-12 17:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IVIVC with literature IV/IR data to serve as impulse func. JMCardot 2012-07-13 12:13
- IVIVC with literature IV/IR data to serve as impulse func.jag009 2012-07-18 23:18
- IVIVC with literature IV/IR data to serve as impulse func. JMCardot 2012-07-20 06:46
- IVIVC with literature IV/IR data to serve as impulse func.jag009 2012-07-18 23:18
- IVIVC with literature IV/IR data to serve as impulse func. JMCardot 2012-07-13 12:13
Ing. Helmut Schütz