Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Requesting data for a publication 📥 ♻️ 🚀 📌	General Statistics	Helmut	2021-04-08 17:09	0		11,871
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		165,206
New guidance on Statistical Approaches to Establishing Bioequivalence A first look A first look A first look SAS strikes back SAS strikes back Outliers? Outliers? SAS strikes back model-based BE? model-based BE? Hooker, Moellenhoff et al. are moving MBBE forward model-based BE? A first look A first look Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Speed kills	BE/BA News	Relaxation	2022-12-02 15:53	22	2023-02-07 13:02	2,350
Documentation of SS for LAI	Design Issues	Achievwin	2023-02-06 13:40	0		52
Suitability System Test?	Bioanalytics	niel	2023-02-05 09:27	0		90
ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) : FDA web site	BE/BA News	Helmut	2022-12-23 09:05	6	2023-02-01 14:14	1,104
Study Design- Two treatment or Four treatment Study Design- Two treatment or Four treatment Study Design- Two treatment or Four treatment Study Design- Two treatment or Four treatment Study Design- Two treatment or Four treatment	Design Issues	NK	2023-01-23 09:38	4	2023-01-24 03:37	477
IMP retention quantity requirement for Japan market	Regulatives / Guidelines	Rahul Metangale	2023-01-23 11:31	0		254
M10 Q&A dated 16 Jan 2023	Regulatives / Guidelines	ElMaestro	2023-01-20 09:32	0		299
Medicines for Europe: 2nd BE Workshop Medicines for Europe: 2nd BE Workshop Medicines for Europe: 2nd BE Workshop	Conferences / Workshops	Helmut	2022-12-10 09:43	2	2023-01-18 09:48	1,027
Biowaiver for site transfer in Mexico	Regulatives / Guidelines	jag009	2023-01-17 14:57	0		247
Questions on understanding the 4-way RSABE method SAS code Questions on understanding the 4-way RSABE method SAS code Questions on understanding the 4-way RSABE method SAS code	RSABE / ABEL	WinnieH	2023-01-04 13:33	2	2023-01-04 15:12	559
FDA's HVD SAS Code / Standard Error / CV FDA's HVD SAS Code / Standard Error / CV FDA's HVD SAS Code / Standard Error / CV CV limbo CV limbo CV limbo CV limbo CV limbo CV limbo	Regulatives / Guidelines	j_kevin	2022-12-08 09:41	8	2023-01-04 11:39	1,419
Chili guidelines ANAMED	Regulatives / Guidelines	gsrao2022	2022-12-25 16:17	1	2022-12-27 09:42	661
How to calculate Within-subject variability in a replicated BE Models, models!	General Statistics	Brus	2022-12-25 09:21	1	2022-12-25 12:17	730