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RegisterOmeprazole [Design Issues]
posted by Helmut 
– Vienna, Austria, 2012-05-15 21:00 (5139 d 23:57 ago) – Posting: # 8572
Views: 12,110
Dear Dr. Gunarsakaran,
THX for digging out these PARs. Always interesting reading matter.
“The primary pharmacokinetic variables evaluated for single dose studies were AUC0-t and Cmax and for steady state, AUCτ and Cmax. Bioequivalence was determined based on limits of 80-125% for AUC and 70-143% for Cmax.
Based on the pharmacokinetic parameters of omeprazole, it can be concluded that Omeprazol “Copyfarm” and Losec/Antra tablets from AstraZeneca are bioequivalent with respect to rate and extent of absorption, and fulfil the bioequivalence requirements outlined in the relevant CHMP Note for Guidance.” (my emphasis)
The 2001 NfG stated:
The 2006 Q&A document stated:
The upper CLs of Cmax were 137% (10mg, fasting, MD), 142% (20mg, fed, SD), 135% (20mg, fasting, MD). It’s good to see that – even in Denmark – assessors didn’t take guidelines literally.* BTW, in the only replicate design study (20mg, fasting, SD) CVintra of Cmax was 45%.
THX for digging out these PARs. Always interesting reading matter.
❝ Public Assessment Report 1 Omeprazol “Copyfarm” Omeprazole
“The primary pharmacokinetic variables evaluated for single dose studies were AUC0-t and Cmax and for steady state, AUCτ and Cmax. Bioequivalence was determined based on limits of 80-125% for AUC and 70-143% for Cmax.
Based on the pharmacokinetic parameters of omeprazole, it can be concluded that Omeprazol “Copyfarm” and Losec/Antra tablets from AstraZeneca are bioequivalent with respect to rate and extent of absorption, and fulfil the bioequivalence requirements outlined in the relevant CHMP Note for Guidance.” (my emphasis)
The 2001 NfG stated:
In certain cases a wider interval may be acceptable. The interval must be prospectively defined e.g. 0.75-1.33 and justified addressing in particular any safety or efficacy concerns for patients switched between formulations.
(my emphasis again)The 2006 Q&A document stated:
The possibility offered here by the guideline to widen the acceptance range of 0.80 – 1.25 for the ratio of Cmax (not for AUC) should be considered exceptional and limited to a small widening (0.75 − 1.33).
… applicable only if CVWR >30% was demonstrated in a replicate design study.The upper CLs of Cmax were 137% (10mg, fasting, MD), 142% (20mg, fed, SD), 135% (20mg, fasting, MD). It’s good to see that – even in Denmark – assessors didn’t take guidelines literally.* BTW, in the only replicate design study (20mg, fasting, SD) CVintra of Cmax was 45%.
- At least not in April 2009.
—
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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
Complete thread:
- Omeprazole joyjac 2012-05-15 09:22 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Omeprazole drgunasakaran1 2012-05-15 09:50
- OmeprazoleHelmut 2012-05-15 19:00
- Omeprazole pash413 2012-12-06 18:09
- Cmax at tlast Helmut 2012-12-07 15:29
- Omeprazole, widen of Cmax in a normal crossover design? wienui 2016-04-07 11:00
- Omeprazole reference = HVDP Helmut 2016-04-07 12:57
- Omeprazole pash413 2012-12-06 18:09
- OmeprazoleHelmut 2012-05-15 19:00
- Omeprazole drgunasakaran1 2012-05-15 09:50
Ing. Helmut Schütz