khaoula
★    

Algeria,
2014-11-23 18:35
(3413 d 12:16 ago)

Posting: # 13918
Views: 3,428
 

 Guideline Health Canada [Regulatives / Guidelines]

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
Helmut
★★★
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Vienna, Austria,
2014-11-23 18:55
(3413 d 11:57 ago)

@ khaoula
Posting: # 13919
Views: 2,948
 

 Generally no dose-correction

Hi Khaoula,

the guidance you are referring to is 22 years old and obsolete. HC removed the dose correction already in the 2009 draft. This part of the current guidance is harmonized with EMA’s and FDA’s requirements.

According to EMA you can apply a dose-correction if you have evidence that it was not possible to find a batch of the reference which does not differ ≤±5% to the test. The intention to use a dose-cor­rec­tion has to be stated and justified in the protocol. Switching after the study was performed is not acceptable. “This is the reference I got in the pharmacy next door” is not a justification.

FDA no idea.

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khaoula
★    

Algeria,
2014-11-23 19:16
(3413 d 11:35 ago)

@ Helmut
Posting: # 13920
Views: 2,961
 

 Generally no dose-correction

thank you verry much !!!! :)
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