Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	WinnieH	2023-01-04 13:33	2	2023-01-04 15:12	528
scale average bioequivalence for parallel design Parallel design: Maybe (‼) in exceptional cases Parallel design: Maybe (‼) in exceptional cases	Mahmoud	2022-06-15 12:33	2	2022-06-15 21:26	921
Sample size and power	Helmut	2022-03-28 13:39	0		648
Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design NTIDs	Sereng	2022-01-28 19:37	3	2022-01-29 11:19	1,005
FDA: SAS-code for NTIDs FDA: SAS-code for NTIDs	Bebac user	2021-12-06 00:36	1	2021-12-06 09:55	1,247
Inter-subject variability in Full replicate design Inter-subject variability in Full replicate design Inter-subject variability in Full replicate design	MGR	2021-09-30 07:35	2	2021-09-30 13:25	1,391
If we have any methods to widen CI in parallel design with high variance drug? If we have any methods to widen CI in parallel design with high variance drug? If we have any methods to widen CI in parallel design with high variance drug?	libaiyi	2021-02-02 09:39	2	2021-02-02 10:40	1,548
95% upper bound limit as per FDA for fully replicate crossover BE study 95% upper bound limit as per FDA for fully replicate crossover BE study 0.001 > 0 0.001 > 0	yogeshla	2021-01-05 07:01	3	2021-01-05 11:33	1,665
Inflated type I error with fixed widened limits? Inflated type I error with fixed widened limits? Inflated type I error with fixed widened limits? Inflated type I error with fixed widened limits Inflated type I error: Not nice Power of the GCC framework and power of PowerTOST Sample sizes (ignoring the inflated TIE) Bug? “Feature” Inflated type I error with fixed widened limits? Inflated type I error with fixed widened limits Inflated type I error with fixed widened limits Inflated type I error with fixed widened limits Houston, we have a problem! Paradox of tolerance Οὐτοπεία ∨ Εὐτοπεία Uchronia Steampunk Dieselpunk Dieselpunk Steampunk? OT Steampunk? OT PowerTOST 1.5-2.9000 on GitHub	Helmut	2020-11-25 10:50	22	2020-12-23 11:18	5,089
Estimate the sample size HVD AUC (by ABE) and Cmax (by ABEL): power AUC (by ABE) and Cmax (by ABEL): power	Yura	2020-12-03 08:47	2	2020-12-04 07:11	1,495
Is Cmax 95% Upper bound 0.0024 = Zero? 0.0024 > 0 ■ 0.0024 > 0 ■	Sereng	2020-10-22 20:30	2	2020-10-23 05:06	2,203
ABEL: Type I Error Wow! ABEL: Type I Error Lost in translation	Helmut	2020-09-28 17:12	3	2020-09-29 08:49	1,676
Partial replicate design: reference(s)? Partial replicate design: reference(s)? Partial replicate design: reference(s)? Hyslop's Alternative Cross-over Designs for Individual Bioequivalence Terry’s homebrew impressive homebrew impressive indeed Partial replicate design: reference(s)? Donald’s model Donald’s model - model for (logistic) groups Donald’s model - model for (logistic) groups Interlude I (sample sizes, problems & remedies) Interlude II (simulations) Interlude II (simulations)	Helmut	2020-08-13 14:22	13	2020-08-19 20:26	5,663
Ratio calculation of fully replicate study Ratio calculation of fully replicate study Ratio calculation of fully replicate study Ratio calculation of fully replicate study Ratio calculation of fully replicate study Purpose? Purpose? Purpose? Purpose? Purpose?	Mithu	2020-07-09 09:18	9	2020-07-10 06:00	3,801
Missing periods in replicate designs Missing periods in replicate designs Missing samples Missing ambulatory samples Missing ambulatory samples Missing ambulatory samples Missing periods in replicate designs Missing periods in replicate designs Missing periods in replicate designs Missing periods in replicate designs Missing periods in replicate designs: save the data? Missing periods in replicate designs: save the data? Missing periods in replicate designs: kill the data? Meaningful data? Missing periods in replicate designs Kenward-Roger? Kenward-Roger? Kenward-Roger ≥ Satterthwaite Kenward-Roger ≥ Satterthwaite Kenward-Roger - links Kenward-Roger - links degrees of freedom degrees of freedom	Helmut	2019-10-16 13:14	22	2020-04-09 14:54	10,374