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RegisterBE in Chinese Pharmacopoeia [Study Assessment]
❝ BTW, is calculation of AUC0→∞ as AUC0→tn+Ctn/λz (given on page 5) mandatory or just a suggestion, i.e., can one use the estimated Ctn instead?
It read that Ctn is the concentration at the last point. No mention of observed or predicted; but from the context I'd say that they are asking for the observed.
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All the best,
Shuanghe
All the best,
Shuanghe
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
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- 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 PharmacopoeiaShuanghe 2013-06-14 14:56
- BE in Chinese Pharmacopoeia Helmut 2013-06-14 16:11
- BE in Chinese PharmacopoeiaShuanghe 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