- NDA and ANDA Bio study NK 2026-03-13 06:26 [Regulatives / Guidelines]
- NDA and ANDA Bio study dshah 2026-03-18 06:01
- NDA and ANDA Bio study NK 2026-03-20 06:18
- NDA and ANDA Bio study dshah 2026-03-18 06:01
- 🧸: installation of bear would fail for Windows yjlee168 2026-03-10 18:48 [🇷 for BE/BA]
- 🪶 Apache Helmut 2026-03-11 09:26
- 🪶 Apache yjlee168 2026-03-11 17:28
- 📣 : 🧸 installation for Windows is back. yjlee168 2026-03-19 18:23
- 🪶 Apache Helmut 2026-03-11 09:26
- everything you ever wanted to know about paired designs martin 2026-03-16 15:42 [General Statistics]
- On CI calculation, untransformed metrics ElMaestro 2019-11-29 03:40 [General Statistics]
- Fieller’s (‘fiducial’) confidence interval Helmut 2019-11-29 10:03
- Fieller’s (‘fiducial’) confidence interval ElMaestro 2019-11-29 15:53
- Fieller’s (‘fiducial’) confidence interval d_labes 2019-11-29 17:20
- Fieller’s (‘fiducial’) confidence interval ElMaestro 2019-11-30 05:11
- power.TOST with logscale=FALSE d_labes 2019-11-30 14:01
- Fieller’s (‘fiducial’) confidence interval apapanas 2026-03-12 10:54
- Fieller’s (‘fiducial’) confidence interval ElMaestro 2019-11-30 05:11
- Fieller’s (‘fiducial’) confidence interval d_labes 2019-11-29 17:20
- Fieller’s (‘fiducial’) confidence interval ElMaestro 2019-11-29 15:53
- On CI calculation, untransformed metrics PharmCat 2019-11-29 12:05
- Fieller’s (‘fiducial’) confidence interval Helmut 2019-11-29 10:03
- 90% CI not contain the 1% Brus 2026-03-06 13:02 [General Statistics]
- 90% CI not containing 100% Helmut 2026-03-06 15:30
- 90% CI not containing 100% Brus 2026-03-11 11:22
- 90% CI not containing 100% Helmut 2026-03-11 15:13
- 90% CI not containing 100% Brus 2026-03-11 11:22
- 90% CI not containing 100% Helmut 2026-03-06 15:30
- ICH M13B: Step 2b (draft for consultation) Helmut 2025-03-15 10:31 [BE/BA News]
- ICH M13B: EMA Helmut 2025-04-09 09:10
- ICH M13B: Step 2b (draft for consultation) Nirali 2026-03-04 18:59
- new regression rule for lambda_z in Phoenix: bug or new feature? Shuanghe 2025-11-10 15:55 [Software]
- new regression rule for lambda_z in Phoenix: bug or new feature? Helmut 2025-11-11 08:42
- new regression rule for lambda_z in Phoenix: no change in implementation SDavis 2025-11-11 14:24
- new regression rule for lambda_z in Phoenix: no change in implementation Shuanghe 2025-11-11 22:38
- Old User’s Guides Helmut 2025-11-11 23:20
- Misinterpretation Helmut 2025-11-12 12:16
- Misinterpretation Shuanghe 2025-11-12 21:24
- Misinterpretation Helmut 2025-11-15 09:38
- Misinterpretation billdenney 2026-02-27 14:20
- Clarification Helmut 2026-02-27 15:29
- Misinterpretation Shuanghe 2025-11-12 21:24
- Rewording appreciated Helmut 2025-11-12 10:30
- Reason for failing to calculate lambda and Kel in Phoenix jag009 2026-01-29 04:20
- Reason for failing to estimate λz Helmut 2026-01-29 11:04
- Reason for failing to calculate lambda and Kel in Phoenix jag009 2026-01-29 04:20
- new regression rule for lambda_z in Phoenix: no change in implementation Shuanghe 2025-11-11 22:38
- Bioanalytical cross validation Brus 2026-02-12 16:04 [Bioanalytics]
- Bioanalytical cross validation Helmut 2026-02-13 09:47
- Bioanalytical cross validation Brus 2026-02-25 13:20
- Bioanalytical cross validation dshah 2026-02-27 11:12
- Bioanalytical cross validation Brus 2026-02-25 13:20
- Bioanalytical cross validation Helmut 2026-02-13 09:47
- Bioequivalence concluded only in AUC Brus 2026-02-25 13:39 [Regulatives / Guidelines]
- Bioequivalence concluded only in AUC dshah 2026-02-26 08:44
- Simulation of inter-subject variability in replicate study Shuanghe 2025-12-14 17:35 [RSABE / ABEL]
- Simulation of inter-subject variability in replicate study mittyri 2025-12-18 14:07
- Simulation of inter-subject variability in replicate study Shuanghe 2025-12-30 10:22
- ABE for partial replicate design acc. to the FDA Helmut 2025-12-30 11:11
- ABE for partial replicate design acc. to the FDA Nirali 2026-02-18 12:04
- ABE for partial replicate design acc. to the FDA Helmut 2025-12-30 11:11
- Simulation of inter-subject variability in replicate study Shuanghe 2025-12-30 10:22
- Simulation of inter-subject variability in replicate study mittyri 2025-12-18 14:07
- Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product A.Shtaiwi 2026-02-02 08:32 [Regulatives / Guidelines]
- Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product dshah 2026-02-18 07:04
- Amoxicillin suspension BE study for Canada bebacrk 2026-02-16 11:37 [Design Issues]
- is open label study acceptable for Canada after implementation of ICH M13A bebacrk 2026-02-12 05:14 [Regulatives / Guidelines]
- HC: open label studies acc. to ICH M13A Helmut 2026-02-12 09:03
- HC: open label studies acc. to ICH M13A bebacrk 2026-02-12 09:53
- HC: outliers in replicate designs? Helmut 2026-02-13 10:33
- HC: open label studies acc. to ICH M13A bebacrk 2026-02-12 09:53
- HC: open label studies acc. to ICH M13A Helmut 2026-02-12 09:03
- Reanalysis reasons Loky do 2025-11-19 11:40 [Bioanalytics]
- Reanalysis reasons dshah 2025-11-20 11:04
- Reanalysis reasons qualityassurance 2025-12-05 14:06
- Reanalysis reasons Achievwin 2026-02-06 12:31
- PK reasons → history Helmut 2026-02-09 11:40
- Blindly (‼) accepting bias? Helmut 2026-02-09 12:41
- Re-analysis: Here we go again ElMaestro 2026-02-09 13:51
- Re-analysis: Here we go-go Helmut 2026-02-10 12:17
- Re-analysis: Here we go again ElMaestro 2026-02-09 13:51
- Reanalysis reasons Achievwin 2026-02-06 12:31
- Venetoclax film-coated tablets study requirement gsrao2022 2026-01-16 16:21 [Regulatives / Guidelines]
- Venetoclax film-coated tablets study requirement A.Shtaiwi 2026-02-02 08:46
