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RegisterDose proportionality [Regulatives / Guidelines]
Dear HS!
Thanks for the credit; however I am not a DP-expert
. Anyway, here are my considerations on this topic.
Definition of dose-proportionality: Dose-proportionality of a drug over a certain range means that doubling of the dose within this range leads to doubling of any individual concentration at a given time point.
For this reason, I personally argue for evaluating dose-proportionality based on AUC rather than Cmax as the AUC covers all time points investigated.
Best regards
Martin
Thanks for the credit; however I am not a DP-expert
. Anyway, here are my considerations on this topic.Definition of dose-proportionality: Dose-proportionality of a drug over a certain range means that doubling of the dose within this range leads to doubling of any individual concentration at a given time point.
For this reason, I personally argue for evaluating dose-proportionality based on AUC rather than Cmax as the AUC covers all time points investigated.
Best regards
Martin
Complete thread:
- Linearity in the new EMA guideline vezz 2010-07-07 09:38
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- Linearity for Biowaiver (Literature) Helmut 2010-07-08 03:41
- Linearity for Biowaiver (Literature) vezz 2010-07-08 09:55
- Dose proportionality Helmut 2010-07-08 13:21
- Dose proportionalitymartin 2010-07-12 12:44
- Dose proportionality Helmut 2010-07-08 13:21
- Linearity for Biowaiver (Literature) vezz 2010-07-08 09:55
- Linearity for Biowaiver (Literature) Helmut 2010-07-08 03:41
Ing. Helmut Schütz