khaoula ★ Algeria, 2014-11-23 18:35 (3413 d 12:16 ago) Posting: # 13918 Views: 3,428 |
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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 |
Helmut ★★★ Vienna, Austria, 2014-11-23 18:55 (3413 d 11:57 ago) @ khaoula Posting: # 13919 Views: 2,948 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
khaoula ★ Algeria, 2014-11-23 19:16 (3413 d 11:35 ago) @ Helmut Posting: # 13920 Views: 2,961 |
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thank you verry much !!!! :) |