Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
6th International Workshop – GBHI 2024: dates announced GBHI 6: Lodging	Conferences / Workshops	SMA	2023-08-30 10:11	1	2024-01-11 13:15	4,372
In-vitro Population Bioequivalence (PBE) Parameters for Particle Size Distribution (PSD)	🇷 for BE/BA	balakotu	2024-01-06 12:23	0		2,323
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	3,514
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	3,738
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	6,288
Mizolastine study design	Design Issues	Bebac user	2023-12-20 18:47	0		1,784
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	3,076
Unannounced inspections, FDA	GxP / QC / QA	ElMaestro	2023-12-19 08:54	0		1,880
Single-dose study in patients Single-dose study in patients Single-dose study in patients	Design Issues	Brus	2023-12-09 17:45	2	2023-12-11 10:44	3,026
FDA/PQRI Workshop about MR	Conferences / Workshops	Helmut	2023-12-09 09:49	0		2,086
Half life longer than literature (or well known) half-life Explain it in the report Explain it in the report Don’t worry, be happy! Don’t worry, be happy!	Study Assessment	jag009	2023-12-06 04:19	4	2023-12-07 16:36	3,434
Amlodipine/Valsartan Amlodipine/Valsartan Amlodipine/Valsartan Amlodipine/Valsartan Amlodipine/Valsartan Use all data and avoid the partial replicate design for the FDA	Design Issues	Bebac user	2023-09-09 06:34	5	2023-12-07 09:01	4,316
Ebastine study design Ebastine study design	Design Issues	Bebac user	2023-11-25 13:07	1	2023-11-27 09:53	3,195
ChatGPT generates fake data set to support scientific hypothesis ChatGPT generates fake data set to support legal case	Off Topic	Helmut	2023-11-24 08:10	1	2023-11-24 15:57	3,058
Outlier in fully replicate BE study Outlier in fully replicate BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study - cherry-picking? Widening for clopidogrel BE study Hypotheses Hypotheses ABEL ≠ RSABE ABEL ≠ RSABE power.TOST.sim and uncertainty power.TOST.sim and uncertainty power.TOST.sim and uncertainty Distribution of PEs Distribution of PEs power.TOST.sim code power.TOST.sim code	Outliers	Loky do	2021-06-16 00:49	17	2023-11-02 11:22	8,509