Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
sampleN.TOST vs. sampleN.scABEL ABEL is a framework (decision scheme) ABEL is a framework (decision scheme) ABEL vs. ABE ABEL vs. ABE Being able to read does not hurt… Being able to read does not hurt… Being able to read does not hurt… Vet BE Guideline	Power / Sample Size	BEQool	2024-01-29 11:53	8	2024-02-05 16:49	1,325
power post hoc post hoc power post hoc power Tightening the limits reduces power for a given sample size	🇷 for BE/BA	Imph	2024-01-29 19:24	3	2024-01-30 09:43	1,008
Steady state BE study dosing Circadian rhythm? Steady state BE study dosing AUC in steady state AUC in steady state AUC in steady state	Design Issues	NK	2024-01-19 04:24	5	2024-01-27 22:16	1,360
multiple dose studies multiple dose studies Css level?	Regulatives / Guidelines	Loky do	2024-01-21 16:15	2	2024-01-26 10:03	909
Statistical Method and acceptance	Design Issues	Vismayi	2024-01-23 09:29	0		627
F-CAD	Software	BEQool	2024-01-23 07:40	0		538
Subject effect justification Subject effect justification	General Statistics	Dafni_C	2024-01-17 10:00	1	2024-01-17 12:30	915
New EMA product specific guidance (PSG) New EMA product specific guidance (PSG)	BE/BA News	SMA	2024-01-16 09:51	1	2024-01-17 10:12	993
6th International Workshop – GBHI 2024: dates announced GBHI 6: Lodging	Conferences / Workshops	SMA	2023-08-30 10:11	1	2024-01-11 13:15	1,905
In-vitro Population Bioequivalence (PBE) Parameters for Particle Size Distribution (PSD)	🇷 for BE/BA	balakotu	2024-01-06 12:23	0		766
Go/No-go Decision for Pivotal Study Problematic T/R-ratio… TSD? sample size for TSD is better than for 1SD?	Power / Sample Size	NK	2023-12-27 12:15	3	2024-01-01 19:54	1,372
Selection of points for Elimination rate constant Don’t include tmax Don’t include tmax Fishy Fishy	NCA / SHAM	ryraman2661	2023-12-23 08:41	4	2023-12-28 12:19	1,169
Adaptive Design for the FDA’s RSABE? Likely it does not work (potentially inflated Type I Error) Exploring package adaptIVPT, function rss() Extreme test case Extreme GMR PE outside {0.80, 1.25} not possible PE outside {0.80, 1.25} not possible Forget rss() Forget rss() TSD useful at all?	Two-Stage / GS Designs	Helmut	2023-12-18 11:20	9	2023-12-26 12:50	2,350
Mizolastine study design	Design Issues	Bebac user	2023-12-20 18:47	0		637
update: bootf2BCA v1.3.2 is out at SourecForge bootf2BCA - Folder does not exist? - Windows only (solved)	Software	yjlee168	2023-12-18 01:39	1	2023-12-20 07:01	809