Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission	Regulatives / Guidelines	jansari	2023-02-21 17:28	6	2023-03-01 15:34	4,251
Documentation of SS for LAI Documentation of SS for LAI	Design Issues	Achievwin	2023-02-06 13:40	1	2023-02-28 16:50	3,075
Are Statistical Analysis Plans “required” for Pivotal Studies? SAP vs. part of the clinical protocol SAP vs. part of the clinical protocol Traceability Are Statistical Analysis Plans “required” for Pivotal Studies? Are Statistical Analysis Plans “required” for Pivotal Studies?	General Statistics	Sereng	2023-02-08 18:23	5	2023-02-16 06:55	4,746
Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind Blinded NCA in Phoenix/WinNonlin Blinded NCA in Phoenix/WinNonlin Blinded NCA in Phoenix/WinNonlin Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind Phoenix: Locked Workflows Phoenix: Locked Workflows Blind forever? Blind forever?	General Statistics	Imph	2023-02-12 08:31	8	2023-02-15 11:00	4,982
Tmax in Partial Replicate Design Good question! Good question! Early exposure (+scaling?) Tmax in Partial replicate design Tmax in Partial replicate design Intra-subject contrast (difference) Intra-subject contrast (difference) Wilcoxon for 2x2x4. "Not many things easier than that"? Tmax in Partial replicate design ISC and Wilcoxon signed rank test ISC and Wilcoxon signed rank test in coin package ISC and Wilcoxon signed rank test in coin package	Nonparametrics	Joshua	2012-01-17 06:59	12	2023-02-14 18:44	17,051
Deconvolution sample size and design issues Deconvolution sample size and design issues Deconvolution sample size and exponential terms Deconvolution sample size and exponential terms	Power / Sample Size	mittyri	2023-02-09 14:40	3	2023-02-10 09:34	3,670
Biowaiver for site transfer in Mexico Biowaiver for site transfer in Mexico	Regulatives / Guidelines	jag009	2023-01-17 14:57	1	2023-02-08 01:59	2,930
Suitability System Test?	Bioanalytics	niel	2023-02-05 09:27	0		2,069
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	4,010
IMP retention quantity requirement for Japan market	Regulatives / Guidelines	Rahul Metangale	2023-01-23 11:31	0		2,469
M10 Q&A dated 16 Jan 2023	Regulatives / Guidelines	ElMaestro	2023-01-20 09:32	0		2,790
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	4,639
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	3,740
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 12:39	6,937
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	4,040