Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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 13:01	15,456
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 11:33	445
Missing periods in replicate designs Missing periods in replicate designs Missing 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	19	2019-11-09 19:11	1,091
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 14:38	727
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 17:19	493
WHO: scaling for AUC ? WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau!	Ohlbe	2017-06-12 13:29	5	2019-06-11 18:51	5,554
EAC: ABEL	Helmut	2019-05-20 19:58	0		564
FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID β = 1 – π Warfarin Sodium 95% Upper bound criteria Upper bound in RSABE ≤0 Upper bound in RSABE ≤0	Jay	2018-03-26 13:31	8	2019-02-12 07:10	5,035
Ratio % in ABE vs. Point Estimate in RSABE Specify the question Specify the question 3b vs ABE PE FDA RSABE Data?	Ahikal	2019-01-27 17:49	4	2019-02-02 13:31	1,249
ilat and dlat ilat and dlat in Progesterone guidance ilat and dlat in Progesterone guidance	Ahikal	2019-01-27 17:52	2	2019-01-29 09:00	920
RSABE - Sequence Suggested: TRT\|RTR Suggested: TRT\|RTR	Sundar.M	2018-09-27 11:11	2	2018-09-28 13:36	1,329
Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Full Replicate Design Group Effect in Replicate Design Group Effect in Replicate Design	GM	2018-09-12 07:17	9	2018-09-13 11:34	3,146
Parallel design - Reference scale Parallel design & Reference-scaling Parallel design & Reference-scaling	Sundar.M	2018-09-07 14:17	2	2018-09-08 17:05	1,465
Calculate the BE limits for HVDPs based on EMA Calculate the BE limits for HVDPs based on EMA (Expanded) BE limits, EMA-style (Expanded) BE limits, EMA-style CFDA: Yet another story? CFDA: Yet another story? CFDA: Draft guidance? CFDA: Draft guidance? Hypotheses generated “in face of the data” Hypotheses generated “in face of the data”	libaiyi	2018-06-08 11:41	9	2018-06-14 03:46	3,281
[Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 Black Swan again [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 Paper & Presentations Donald Schuirmann’s opinion	bebac_fan	2018-03-28 18:43	18	2018-04-10 14:41	6,825