Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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	4,701
EAC: ABEL	Helmut	2019-05-20 19:58	0		307
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	3,447
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	713
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	544
RSABE - Sequence Suggested: TRT\|RTR Suggested: TRT\|RTR	Sundar.M	2018-09-27 11:11	2	2018-09-28 13:36	918
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	2,026
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	1,012
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 CFDA: Draft guidance? CFDA: Draft guidance?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	2,362
[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	5,665
Full replicate designed study for Europe Full replicate designed study for Europe Full replicate designed study for Europe	balakotu	2018-03-31 11:59	2	2018-04-02 02:19	1,538
95% Upper bound calculation 95% Upper bound calculation 95% Upper bound calculation 95% Upper bound calculation	GM	2018-03-07 06:25	3	2018-03-13 09:31	1,758
question of adjustment TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE = p(BE) at expanded limits TIE = p(BE) at expanded limits TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) Comparing methods for (S)ABE Comparing methods for (S)ABE Simulating the Null Adjusting α	Yura	2017-04-25 15:14	14	2018-03-07 16:21	7,268
Validation of FDA's RSABE on NTIDs Validation of FDA's RSABE on NTIDs Validation of FDA's RSABE on NTIDs Validation of FDA's RSABE on NTIDs Validation of FDA's RSABE on NTIDs Validation of FDA's RSABE on NTIDs Clarification needed: Validation of FDA's RSABE on NTIDs FDA's RSABE on NTIDs in R FDA's RSABE on NTIDs in R FDA's RSABE on NTIDs in R	yicaoting	2017-08-22 18:01	9	2018-03-01 23:39	10,818
Which is better for missing periods PROC GLM or PROC MIXED EMA: Method A or B EMA: Method A or B	Mohamed Yehia	2018-01-23 09:48	2	2018-01-23 11:56	2,064