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good evening everybody,
I have à question, I read an interessant topic in this guideline of Health Canada " Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects (1992)", and I found the method of calculating the AUC ratio and Cmax ratio estimates and their confidence limits, based on data corrected for measured content, so the natural logarithm of (Measured content of R/ Measured content of T)of the analytical dosage before the study is used as a corrective factor to calculate AUC ratio and Cmax ratio.
my question is: the part of this guideline that addresses this topic disappeared in the new guideline "Conduct and Analysis of Comparative Bioavailability Studies and Comparative Bioavailability standards: Formulations used for Systemic Effects" 2012, and I did'nt find this information anywhere
Why? is anyone have an answer ? is this method acceptable by others authorities like FDA and EMA?
thank you
I have à question, I read an interessant topic in this guideline of Health Canada " Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects (1992)", and I found the method of calculating the AUC ratio and Cmax ratio estimates and their confidence limits, based on data corrected for measured content, so the natural logarithm of (Measured content of R/ Measured content of T)of the analytical dosage before the study is used as a corrective factor to calculate AUC ratio and Cmax ratio.
my question is: the part of this guideline that addresses this topic disappeared in the new guideline "Conduct and Analysis of Comparative Bioavailability Studies and Comparative Bioavailability standards: Formulations used for Systemic Effects" 2012, and I did'nt find this information anywhere
Why? is anyone have an answer ? is this method acceptable by others authorities like FDA and EMA?
thank you
Complete thread:
- Guideline Health Canadakhaoula 2014-11-23 17:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Generally no dose-correction Helmut 2014-11-23 17:55
- Generally no dose-correction khaoula 2014-11-23 18:16
- Generally no dose-correction Helmut 2014-11-23 17:55
Ing. Helmut Schütz