Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Requesting data for a publication 📥 ♻️ 🚀 📌 Requesting data for a presentation	General Statistics	Helmut	2021-04-08 17:09	1	2023-02-23 10:46	19,334
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		165,490
where can I find Old FDA PSG	Regulatives / Guidelines	Achievwin	2023-03-24 14:51	0		24
UK/EU IMP Labelling requirement for Comporator used in BE studies UK/EU IMP Labelling requirement for Comporator used in BE studies	Regulatives / Guidelines	HallaGulla	2023-03-22 12:34	1	2023-03-24 13:59	100
Upper confidence bound and confidence interval of RSABE	RSABE / ABEL	WinnieH	2023-03-21 10:58	0		98
Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Replicate Design ≠ Higher-Order Crossover Thank You! Replicate Design ≠ Higher-Order Crossover	Design Issues	Sereng	2023-03-13 17:08	7	2023-03-20 08:56	434
average bioequivalence: MLE vs. REML average bioequivalence: MLE vs. REML average bioequivalence: MLE vs. REML average bioequivalence: MLE vs. REML	General Statistics	Mahmoud	2023-03-11 12:21	3	2023-03-16 23:51	457
EUFEPS Open Forum: ICH M13 Draft Guideline ICH M13 Draft Guideline: FDA webinar	Conferences / Workshops	Helmut	2023-03-05 12:50	1	2023-03-15 11:42	388
Pumas AI: new software for Pharmacokinetic Modeling Pumas AI Pumas AI Pumas AI	Software	Rayhope	2023-03-03 05:09	3	2023-03-14 20:55	411
EU Transdermal Patch: Generic Submission	Design Issues	HallaGulla	2023-03-08 08:58	0		163
Sample size for replicate crossover studies Sample size for replicate crossover studies Sample size for replicate crossover studies Sample size for replicate crossover studies	Power / Sample Size	Imph	2023-03-06 14:29	3	2023-03-07 11:30	355
Variance VS Coefficient of variation s² ↔ CV CV ≈ s for low variances CV ≈ s for low variances CV ≈ s for low variances	General Statistics	Imph	2023-02-27 09:09	4	2023-03-06 12:42	602
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	892
Documentation of SS for LAI Documentation of SS for LAI	Design Issues	Achievwin	2023-02-06 13:40	1	2023-02-28 16:50	520
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 Multi-group studies ad nauseam Speed kills	BE/BA News	Relaxation	2022-12-02 15:53	23	2023-02-25 16:18	3,316