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RegisterOh wow! [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2013-05-27 18:21 (4773 d 14:49 ago) – Posting: # 10667
Views: 16,591
Hi Two Rivers!
Oh wow! With such limits AUC is really the win-loose-metric. Are you referring to the 2005 GL?
I wish him good luck in setting up simulations to find a suitable αadj. for [0.70–1.43]. None of the published methods would work.
Well, hundreds of products were approved in the EU with those limits – but decades ago…
❝ From the Xipei's habit of estimating sample size with AUC I assume this is a study for Chinese regulation. If so, the Chinese BE guideline reads that criterion for AUC is 80-125 but for Cmax, hold-on, deep breath, …, 70-143% (and the study doesn't even have to be of replicate design 
)
Oh wow! With such limits AUC is really the win-loose-metric. Are you referring to the 2005 GL?
等效判断标准，一般规定，经对数转换后的受试制剂的AUC0→t 在参比 制剂的80％-125％范围，受试制剂的Cmax 在参比制剂的70％-143％范围。
I wish him good luck in setting up simulations to find a suitable αadj. for [0.70–1.43]. None of the published methods would work.
❝ OK, now you can pick the draw you just dropped on the ground. 
Well, hundreds of products were approved in the EU with those limits – but decades ago…
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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:
- Add more subjects after a failed BE study of a HVD wxp 2013-05-27 10:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- bad luck Dr_Dan 2013-05-27 12:28
- bad luck wxp 2013-05-27 14:19
- Beware of Add-on Studies! Helmut 2013-05-27 13:51
- Beware of Add-on Studies! Shuanghe 2013-05-27 15:59
- Oh wow!Helmut 2013-05-27 16:21
- The same criterion of Cmax in China now wxp 2013-05-28 06:10
- SFDA ⇒ CFDA Helmut 2013-05-28 13:02
- Helmut, updated Chinese BE guideline here Shuanghe 2013-06-14 11:05
- BE in Chinese Pharmacopoeia Helmut 2013-06-14 14:22
- BE in Chinese Pharmacopoeia Shuanghe 2013-06-14 14:56
- BE in Chinese Pharmacopoeia Helmut 2013-06-14 16:11
- BE in Chinese Pharmacopoeia Shuanghe 2013-06-14 14:56
- BE in Chinese Pharmacopoeia Helmut 2013-06-14 14:22
- Helmut, updated Chinese BE guideline here Shuanghe 2013-06-14 11:05
- SFDA ⇒ CFDA Helmut 2013-05-28 13:02
- The same criterion of Cmax in China now wxp 2013-05-28 06:10
- Oh wow!Helmut 2013-05-27 16:21
- Add more subjects after a failed BE study of a HVD wxp 2013-05-28 05:13
- Still many subjects… Helmut 2013-05-28 12:56
- Beware of Add-on Studies! Shuanghe 2013-05-27 15:59
- bad luck Dr_Dan 2013-05-27 12:28
Ing. Helmut Schütz