Log in
Registerbad luck [Study Assessment]
Dear wxp
a BE study is a pivotal study and so unfortunately it will not be possible to add another group of subjects since this has to be pre-specified in the protocol. Furthermore appropriate steps to preserve the overall type I error (patient’s risk) have to be considered.
For further information please see Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ, and RA Smith: Sequential design approaches for bioequivalence studies with crossover designs. Pharmaceut Statist 7/4, 245–62 (2008)
Kind regards
Dan
a BE study is a pivotal study and so unfortunately it will not be possible to add another group of subjects since this has to be pre-specified in the protocol. Furthermore appropriate steps to preserve the overall type I error (patient’s risk) have to be considered.
For further information please see Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ, and RA Smith: Sequential design approaches for bioequivalence studies with crossover designs. Pharmaceut Statist 7/4, 245–62 (2008)
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
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 luckDr_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 luckDr_Dan 2013-05-27 12:28
Ing. Helmut Schütz