Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
NDA and ANDA Bio study NDA and ANDA Bio study NDA and ANDA Bio study	Regulatives / Guidelines	NK	2026-03-13 06:26	2	2026-03-20 06:18	1,391
🧸: installation of bear would fail for Windows 🪶 Apache 🪶 Apache 📣 : 🧸 installation for Windows is back.	🇷 for BE/BA	yjlee168	2026-03-10 18:48	3	2026-03-19 18:23	1,670
everything you ever wanted to know about paired designs	General Statistics	martin	2026-03-16 15:42	0		773
On CI calculation, untransformed metrics Fieller’s (‘fiducial’) confidence interval Fieller’s (‘fiducial’) confidence interval Fieller’s (‘fiducial’) confidence interval Fieller’s (‘fiducial’) confidence interval power.TOST with logscale=FALSE Fieller’s (‘fiducial’) confidence interval On CI calculation, untransformed metrics	General Statistics	ElMaestro	2019-11-29 03:40	7	2026-03-12 10:54	8,714
90% CI not contain the 1% 90% CI not containing 100% 90% CI not containing 100% 90% CI not containing 100%	General Statistics	Brus	2026-03-06 13:02	3	2026-03-11 15:13	1,380
ICH M13B: Step 2b (draft for consultation) ICH M13B: EMA ICH M13B: Step 2b (draft for consultation)	BE/BA News	Helmut	2025-03-15 10:31	2	2026-03-04 18:59	6,903
new regression rule for lambda_z in Phoenix: bug or new feature? new regression rule for lambda_z in Phoenix: bug or new feature? new regression rule for lambda_z in Phoenix: no change in implementation new regression rule for lambda_z in Phoenix: no change in implementation Old User’s Guides Misinterpretation Misinterpretation Misinterpretation Misinterpretation Clarification Rewording appreciated Reason for failing to calculate lambda and Kel in Phoenix Reason for failing to estimate λz	Software	Shuanghe	2025-11-10 15:55	12	2026-02-27 15:29	5,071
Bioanalytical cross validation Bioanalytical cross validation Bioanalytical cross validation Bioanalytical cross validation	Bioanalytics	Brus	2026-02-12 16:04	3	2026-02-27 11:12	1,508
Bioequivalence concluded only in AUC Bioequivalence concluded only in AUC	Regulatives / Guidelines	Brus	2026-02-25 13:39	1	2026-02-26 08:44	1,171
Simulation of inter-subject variability in replicate study Simulation of inter-subject variability in replicate study Simulation of inter-subject variability in replicate study ABE for partial replicate design acc. to the FDA ABE for partial replicate design acc. to the FDA	RSABE / ABEL	Shuanghe	2025-12-14 17:35	4	2026-02-18 12:04	2,500
Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product	Regulatives / Guidelines	A.Shtaiwi	2026-02-02 08:32	1	2026-02-18 07:04	1,191
Amoxicillin suspension BE study for Canada	Design Issues	bebacrk	2026-02-16 11:37	0		821
is open label study acceptable for Canada after implementation of ICH M13A HC: open label studies acc. to ICH M13A HC: open label studies acc. to ICH M13A HC: outliers in replicate designs?	Regulatives / Guidelines	bebacrk	2026-02-12 05:14	3	2026-02-13 10:33	1,383
Reanalysis reasons Reanalysis reasons Reanalysis reasons Reanalysis reasons PK reasons → history Blindly (‼) accepting bias? Re-analysis: Here we go again Re-analysis: Here we go-go	Bioanalytics	Loky do	2025-11-19 11:40	7	2026-02-10 12:17	3,118
Venetoclax film-coated tablets study requirement Venetoclax film-coated tablets study requirement	Regulatives / Guidelines	gsrao2022	2026-01-16 16:21	1	2026-02-02 08:46	1,331