- Unannounced inspections, FDA ElMaestro 2023-12-19 08:54 [GxP / QC / QA]
- Single-dose study in patients Brus 2023-12-09 17:45 [Design Issues]
- Single-dose study in patients Helmut 2023-12-10 09:43
- Single-dose study in patients dshah 2023-12-11 10:44
- FDA/PQRI Workshop about MR Helmut 2023-12-09 09:49 [Conferences / Workshops]
- Half life longer than literature (or well known) half-life jag009 2023-12-06 04:19 [Study Assessment]
- Explain it in the report Helmut 2023-12-06 10:41
- Explain it in the report jag009 2023-12-06 15:46
- Don’t worry, be happy! Helmut 2023-12-06 16:30
- Don’t worry, be happy! jag009 2023-12-07 16:36
- Don’t worry, be happy! Helmut 2023-12-06 16:30
- Explain it in the report jag009 2023-12-06 15:46
- Explain it in the report Helmut 2023-12-06 10:41
- Amlodipine/Valsartan Bebac user 2023-09-09 06:34 [Design Issues]
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
- Amlodipine/Valsartan Kumarnaidu2 2023-12-06 09:36
- Amlodipine/Valsartan dshah 2023-12-06 16:49
- Amlodipine/Valsartan Kumarnaidu2 2023-12-07 02:42
- Use all data and avoid the partial replicate design for the FDA Helmut 2023-12-07 09:01
- Amlodipine/Valsartan dshah 2023-12-06 16:49
- Amlodipine/Valsartan Kumarnaidu2 2023-12-06 09:36
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
- Ebastine study design Bebac user 2023-11-25 13:07 [Design Issues]
- Ebastine study design dshah 2023-11-27 09:53
- ChatGPT generates fake data set to support scientific hypothesis Helmut 2023-11-24 08:10 [Off Topic]
- ChatGPT generates fake data set to support legal case Ohlbe 2023-11-24 15:57
- Outlier in fully replicate BE study Loky do 2021-06-16 00:49 [Outliers]
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
- Widening for clopidogrel BE study Loky do 2021-06-16 15:38
- Widening for clopidogrel BE study mittyri 2021-06-16 16:04
- Widening for clopidogrel BE study Loky do 2021-06-16 17:08
- Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
- Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
- Hypotheses Helmut 2021-06-19 12:32
- Hypotheses Loky do 2021-07-06 11:51
- ABEL ≠ RSABE Helmut 2021-07-06 16:17
- ABEL ≠ RSABE BEQool 2023-10-09 14:47
- power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
- power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
- power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
- Distribution of PEs Helmut 2023-10-23 10:48
- Distribution of PEs BEQool 2023-10-23 19:55
- power.TOST.sim code mittyri 2023-10-31 15:40
- power.TOST.sim code BEQool 2023-11-02 11:22
- power.TOST.sim code mittyri 2023-10-31 15:40
- Distribution of PEs BEQool 2023-10-23 19:55
- Distribution of PEs Helmut 2023-10-23 10:48
- power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
- power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
- power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
- ABEL ≠ RSABE BEQool 2023-10-09 14:47
- ABEL ≠ RSABE Helmut 2021-07-06 16:17
- Hypotheses Loky do 2021-07-06 11:51
- Widening for clopidogrel BE study Loky do 2021-06-16 17:08
- Widening for clopidogrel BE study mittyri 2021-06-16 16:04
- Widening for clopidogrel BE study Loky do 2021-06-16 15:38
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
- BioBridges 2023 Helmut 2023-04-06 10:52 [Conferences / Workshops]
- BioBridges 2023 - lectures available! mittyri 2023-10-31 16:33
- Unusual / Distinct PK profile drug VijithRoy 2023-10-25 16:55 [PK / PD]
- Unusual / Distinct PK profile drug dshah 2023-10-26 15:36
- Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) JP2030 2023-10-18 05:58 [Regulatives / Guidelines]
- EMA: No AUC(0-72h) for all MR products Helmut 2023-10-18 07:09
- open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Performance]
- Blinded NCA Helmut 2023-10-14 10:40
- Blinded NCA kimhuang 2023-10-14 11:53
- Blinded review of PK data: History… Helmut 2023-10-15 10:26
- Blinded review of PK data: History… kimhuang 2023-10-16 00:43
- Blinded review of PK data: History… Helmut 2023-10-15 10:26
- Blinded NCA kimhuang 2023-10-14 11:53
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
- open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
- open-label BE trials maintain blindness dshah 2023-10-17 09:25
- open-label BE trials maintain blindness kimhuang 2023-10-18 00:50
- open-label BE trials maintain blindness dshah 2023-10-17 09:25
- open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
- Blinded NCA Helmut 2023-10-14 10:40
- Application and test region of vasoconstrictor assay Kelen 2023-10-04 16:31 [Regulatives / Guidelines]
- Application and test region of vasoconstrictor assay dshah 2023-10-17 09:34
- Tmax 90% confidence interval durga09 2023-09-08 10:21 [Regulatives / Guidelines]
- Tmax 90% confidence interval Achievwin 2023-09-09 12:44
- link to the post of BEBAC golden collection mittyri 2023-09-10 19:55
- link to the post of BEBAC golden collection durga09 2023-10-10 10:43
- CI for difference in Tmax mittyri 2023-10-11 12:55
- Tmax problems Helmut 2023-10-12 06:55
- link to the post of BEBAC golden collection durga09 2023-10-10 10:43
- link to the post of BEBAC golden collection mittyri 2023-09-10 19:55
- Tmax 90% confidence interval Achievwin 2023-09-09 12:44
- Carry over and statistical adjustment in BE computations Achievwin 2023-10-02 20:34 [General Statistics]
- Carry-over → 🚮 Helmut 2023-10-02 21:06
- Carry-over → 🚮 Achievwin 2023-10-03 12:13
- Carry-over → 🚮 Helmut 2023-10-03 12:48
- Carry-over dshah 2023-10-03 16:34
- Carry-over Achievwin 2023-10-03 20:33
- Carry-over Helmut 2023-10-04 08:31
- Carry-over Achievwin 2023-10-04 16:38
- Carry-over dshah 2023-10-04 11:22
- Carry-over Helmut 2023-10-04 08:31
- more than 20% subject carry over effect investigation mittyri 2023-10-05 20:15
- carry over effect investigation based on what? Helmut 2023-10-06 07:08
- carry over effect investigation based on what? dshah 2023-10-06 13:20
- Carry-over Achievwin 2023-10-03 20:33
- Carry-over → 🚮 Achievwin 2023-10-03 12:13
- Outdated and wrong answers mittyri 2023-10-05 20:34
- Wrong answer Helmut 2023-10-06 07:19
- Carry-over → 🚮 Helmut 2023-10-02 21:06