- Parallel Group Adaptive Designs Alex 2023-12-22 10:08 [Two-Stage / GS Designs]
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
- Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
- Strong Type I Error control + CI: Not yet… Helmut 2024-01-09 09:48
- Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
- Parallel Group Adaptive Designs Achievwin 2024-01-05 11:53
- Simulations highly recommended Helmut 2024-01-05 12:40
- Simulations highly recommended Achievwin 2024-01-08 16:55
- Simulations mandatory Helmut 2024-01-09 09:31
- Simulations mandatory Achievwin 2024-01-09 21:11
- Reviews are confidential Helmut 2024-01-09 22:10
- Reviews are confidential Achievwin 2024-01-19 15:11
- Reviews are confidential Helmut 2024-01-09 22:10
- Simulations mandatory Achievwin 2024-01-09 21:11
- Simulations mandatory Helmut 2024-01-09 09:31
- Simulations highly recommended Achievwin 2024-01-08 16:55
- Simulations highly recommended Helmut 2024-01-05 12:40
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
- Subject effect justification Dafni_C 2024-01-17 10:00 [General Statistics]
- Subject effect justification Relaxation 2024-01-17 12:30
- New EMA product specific guidance (PSG) SMA 2024-01-16 09:51 [BE/BA News]
- New EMA product specific guidance (PSG) dshah 2024-01-17 10:12
- 6th International Workshop – GBHI 2024: dates announced SMA 2023-08-30 10:11 [Conferences / Workshops]
- GBHI 6: Lodging Helmut 2023-08-30 19:06
- In-vitro Population Bioequivalence (PBE) Parameters for Particle Size Distribution (PSD) balakotu 2024-01-06 12:23 [🇷 for BE/BA]
- Go/No-go Decision for Pivotal Study NK 2023-12-27 12:15 [Power / Sample Size]
- Problematic T/R-ratio… Helmut 2023-12-27 13:27
- TSD? Helmut 2024-01-01 13:50
- sample size for TSD is better than for 1SD? mittyri 2024-01-01 19:54
- TSD? Helmut 2024-01-01 13:50
- Problematic T/R-ratio… Helmut 2023-12-27 13:27
- Selection of points for Elimination rate constant ryraman2661 2023-12-23 08:41 [NCA / SHAM]
- Don’t include tmax Helmut 2023-12-23 11:46
- Don’t include tmax ryraman2661 2023-12-26 08:40
- Don’t include tmax Helmut 2023-12-23 11:46
- Adaptive Design for the FDA’s RSABE? Helmut 2023-12-18 11:20 [Two-Stage / GS Designs]
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10
- Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
- Extreme test case Helmut 2023-12-24 13:01
- Extreme GMR Naksh 2023-12-25 04:16
- PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
- PE outside {0.80, 1.25} not possible Naksh 2023-12-25 11:42
- Forget rss() Helmut 2023-12-25 13:15
- Forget rss() Naksh 2023-12-26 04:49
- TSD useful at all? Helmut 2023-12-26 12:50
- Forget rss() Naksh 2023-12-26 04:49
- Forget rss() Helmut 2023-12-25 13:15
- PE outside {0.80, 1.25} not possible Naksh 2023-12-25 11:42
- PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
- Extreme GMR Naksh 2023-12-25 04:16
- Extreme test case Helmut 2023-12-24 13:01
- Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10
- Mizolastine study design Bebac user 2023-12-20 18:47 [Design Issues]
- update: bootf2BCA v1.3.2 is out at SourecForge yjlee168 2023-12-18 01:39 [Software]
- bootf2BCA - Folder does not exist? - Windows only (solved) yjlee168 2023-12-20 07:01
- 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