Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	6,388
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	19,419
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	5,834
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	7,294
ABEL: Type I Error Wow! ABEL: Type I Error Lost in translation	Helmut	2020-09-28 17:12	3	2020-09-29 08:49	6,481
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	14,007
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	10,346
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	20,195
Statistical evaluation and BE hypotheses in full replicate design Inflation of the TIE as well Inflation of the TIE as well Tricky… Tricky… Terrible… Tricky… Deep shit Deep shit Deep shit Deep shit Deep shit Deep shit Deep shit Flawed evaluation accepted Flawed evaluation accepted Flawed evaluation accepted Flawed evaluation accepted Flawed approach even if accepted ? Flawed approach even if accepted ? misunderstanding misunderstanding misunderstanding The globe is flat! Tricky… Tricky… Tricky… ABE vs. ABEL zigzag zigzag zigzag helter-skelter helter-skelter Inflation of the TIE as well Inflation of the TIE as well Inflation of the TIE as well Fishing in the dark Statistical evaluation and BE hypotheses in full replicate design TIE, repeat once more please...	Elena777	2020-01-28 07:02	38	2020-04-02 10:41	37,343
To Russia (with love?) To Russia (with love?) From Russia (with love?) From Russia with review From Russia (with love?) Ignorance is not bliss Ignorance is not bliss Ignorance is not bliss - but this is modus vivendi Ignorance is Strength? So sad! does existence exist? OT: Something and nothing add OT: Everything and Nothing OT: Something and nothing Russian edition OT: Something and nothing Russian edition OT: “Deutscher Humor” OT: “Deutscher Humor” OT: “Deutscher Humor” OT: “Deutscher Humor” OT: Something and nothing	Helmut	2019-12-04 01:21	19	2019-12-07 20:21	16,019
FDA's HVD SAS Code from Progesterone Guidance Proc MIXED vs. Proc GLM Proc MIXED vs. Proc GLM SAS vs. PHX SAS vs. PHX SAS vs. SAS SAS vs. SAS vs. Phoenix SAS vs. PHX SAS Warning (Note) on Proc Mixed Nut Job.. Second opinion (PHX 6.3) Second opinion (PHX 6.3) Second opinion (PHX 6.3) In praise of a full replicate Third opinion Compound Symmetry Compound Symmetry - SASian (1) Variance=0	jag009	2013-04-22 16:39	17	2019-11-12 12:01	35,559
Inflation type one error Inflation type one error Inflation type one error Inflation type one error Inflation type one error: FDA Inflation type one error Inflation type one error Inflation type one error TIE = chance of passing at the border(s)	Mikalai	2019-11-05 18:59	8	2019-11-10 10:33	10,546
subject inclusion question in replicate design for ANVISA subject inclusion question in replicate design for ANVISA subject inclusion question in replicate design for ANVISA	Shuanghe	2019-09-04 14:48	2	2019-09-05 12:38	6,513
REML, ML and MM different BE decision REML, ML and MM different BE decision	M.tareq	2019-07-21 19:09	1	2019-07-22 15:19	5,839
East African Community: ABEL	Helmut	2019-05-20 19:58	0		3,698