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RegisterIVIVC with literature IV/IR data to serve as impulse func. [Regulatives / Guidelines]
Hi,
Is it valid to generate an IVIVC without a 4-way study that involves 3 test ER formulations and IV/IR treatment? Can I generate one with the IR/IV data obtained from literature to serve as the impulse function for deconvoution and convolution steps? Data from 3 test ER formulations will be from one study, i.e., 4-way crossover study compared 3 test ER formulations vs reference ER product.
Thanks
John
Is it valid to generate an IVIVC without a 4-way study that involves 3 test ER formulations and IV/IR treatment? Can I generate one with the IR/IV data obtained from literature to serve as the impulse function for deconvoution and convolution steps? Data from 3 test ER formulations will be from one study, i.e., 4-way crossover study compared 3 test ER formulations vs reference ER product.
Thanks
John
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