Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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	2,847
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	428
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	350
RSABE - Sequence Suggested: TRT\|RTR Suggested: TRT\|RTR	Sundar.M	2018-09-27 11:11	2	2018-09-28 13:36	726
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	1,414
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	753
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 CFDA: Draft guidance? CFDA: Draft guidance?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	1,923
[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	4,853
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	1,393
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	1,523
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	6,556
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	9,919
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	1,833
How to calculate N1,N2,N3 and DF in missing Partial replicate	Junior	2018-01-22 20:33	0		1,059
Partial replicate or Reference scaling Partial replicate ≠ Reference scaling	heaven sent	2017-12-29 17:24	1	2017-12-29 18:36	1,691

Bioequivalence and Bioavailability Forum 13:00 CET