nuka2020 ☆ United Arab Emirates, 2020-11-19 11:09 (151 d 08:19 ago) Posting: # 22067 Views: 880 |
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According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%. But, i have a study which was performed as per Eu guidelines and accordingly, the acceptance criteria for Cmax can be widened to a maximum of 69.84 – 143.19%. Accordingly, the results of Cmax is: 70.46%-141.90% Need suggestion whether this studies can be acceptable as per GCC guidelines?? ![]() ![]() |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2020-11-19 12:05 (151 d 07:23 ago) @ nuka2020 Posting: # 22068 Views: 757 |
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Hi nuka2020, » According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%. » … the results of Cmax is: 70.46%-141.90% » Need suggestion whether this studies can be acceptable as per GCC guidelines?? What do you think? Though you have practically a perfect PE (99.99%) you failed to show BE by far. For the GCC your study was just underpowered. — Dif-tor heh smusma 🖖 Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
wienui ★ Germany, Oman, 2020-11-19 18:04 (151 d 01:24 ago) (edited by wienui on 2020-11-20 07:13) @ nuka2020 Posting: # 22069 Views: 739 |
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Hi nuka & Helmut, » According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%. » But, i have a study which was performed as per Eu guidelines and accordingly, the acceptance criteria for Cmax can be widened to a maximum of 69.84 – 143.19%. Accordingly, the results of Cmax is: 70.46%-141.90% » Need suggestion whether this studies can be acceptable as per GCC guidelines?? ![]() ![]() Unfortunately, we come back again to this point. Although the GCC GL is adopted from the EMA GL, but the upper cap of scaling is about only 39% and not 50%!!!! At the moment, I think you could have a good chance under the conditions that your BE study is demonstrated in a replicate design and that the high within-subject variability for Cmax not caused by outliers. — Cheers, Osama |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2020-11-19 20:58 (150 d 22:30 ago) @ wienui Posting: # 22070 Views: 724 |
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Hi Osama, » Although the GCC GL is adopted from the EMA GL, but the upper cap of scaling is about only 39% and not 50%!!!!
![]() I wouldn’t call that scaling. The GL calls for fixed limits of 75.00–133.33% (based on a “clinically not relevant Δ” of 25%) for any CVwR >30% (there is no upper cap and the widened limits are fixed). That’s the approach mentioned in the EMA’s Q&A-document of July 2006: » At the moment, I think you could have a good chance under the conditions that your BE study is demonstrated in a replicate design and that the high within-subject variability for Cmax not caused by outliers. That’s interesting!
— Dif-tor heh smusma 🖖 Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |