HC Proposed Policy on Bioequivalence Standards for HVDS [Regulatives / Guidelines]
Dear Kotu,
THX for that link.
Interesting! EMA approach but allowed for AUC. Since Cmax doesn't need a CI criterion at all, only a point estimate restriction is imposed.
THX for that link.
Interesting! EMA approach but allowed for AUC. Since Cmax doesn't need a CI criterion at all, only a point estimate restriction is imposed.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05 [Regulatives / Guidelines]
- HC Proposed Policy on Bioequivalence Standards for HVDSd_labes 2015-07-02 09:19
- Bloody partial replicate again Helmut 2015-07-02 13:20
- Bloody partial replicate again Lucas 2015-07-02 13:35
- Which model? Helmut 2015-07-02 16:41
- Which model? Lucas 2015-07-02 18:06
- Which model? Helmut 2015-07-02 16:41
- Bloody partial replicate again Lucas 2015-07-02 13:35
- HC Proposed Policy on Bioequivalence Standards for HVDS drgunasakaran1 2015-07-02 17:08
- AUC and Cmax Helmut 2015-07-02 17:37
- HC for HVDs d_labes 2015-07-03 08:21
- HC for HVDs Helmut 2015-07-03 11:55
- Rounding d_labes 2015-07-03 12:53
- Acceptable difference (BE history) Helmut 2015-07-03 14:49
- Off topic ElMaestro 2015-07-03 13:02
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
- Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
- OT – Philosophers on duty d_labes 2015-07-03 21:11
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
- Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
- Rounding d_labes 2015-07-03 12:53
- HC for HVDs Helmut 2015-07-03 11:55