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	19,453
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		165,526
Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Full Replicate with 3 periods Full Replicate with 3 periods Full Replicate with 3 periods Definition of Full Replicate Replicate Design ≠ Higher-Order Crossover Thank You! Replicate Design ≠ Higher-Order Crossover imbalance in Latin Square	Design Issues	Sereng	2023-03-13 17:08	12	2023-03-28 09:03	587
where can I find Old FDA PSG where can I find Old FDA PSG where can I find Old FDA PSG	Regulatives / Guidelines	Achievwin	2023-03-24 14:51	2	2023-03-27 02:10	166
UK/EU IMP Labelling requirement for Comparator used in BE studies UK/EU IMP Labelling requirement for Comparator used in BE studies	Regulatives / Guidelines	HallaGulla	2023-03-22 12:34	1	2023-03-24 13:59	223
Upper confidence bound and confidence interval of RSABE	RSABE / ABEL	WinnieH	2023-03-21 10:58	0		169
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	522
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	441
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	472
EU Transdermal Patch: Generic Submission	Design Issues	HallaGulla	2023-03-08 08:58	0		201
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	411
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	667
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	951
Documentation of SS for LAI Documentation of SS for LAI	Design Issues	Achievwin	2023-02-06 13:40	1	2023-02-28 16:50	584
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	3,387