Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last Reply	Views
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 CFDA: Draft guidance? CFDA: Draft guidance?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	953
[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	2,483
FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID β = 1 – π	Jay	2018-03-26 13:31	5	2018-04-04 15:03	1,592
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	950
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	908
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	3,790
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	6,082
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	1,133
How to calculate N1,N2,N3 and DF in missing Partial replicate	Junior	2018-01-22 20:33	0		805
Partial replicate or Reference scaling Partial replicate ≠ Reference scaling	heaven sent	2017-12-29 17:24	1	2017-12-29 18:36	972
alpha correction theta0 within PE-constraints [theta1, theta2] theta0 within PE-constraints [theta1, theta2]	Yura	2017-12-08 08:48	2	2017-12-08 12:55	1,176
CI equation for 4 Period, 2 sequences "Full Replicate" DF for 4 Period, 2 sequences "Full Replicate" DF for 4 Period, 2 sequences "Full Replicate"	Mohamed Yehia	2017-10-29 17:00	2	2017-10-29 19:50	1,300
How To calculate CVintra and CVinter	Mohamed Yehia	2017-08-15 15:33	0		1,210
only subjects with TR? only subjects with TR? only subjects with TR?	Helmut	2017-07-11 21:34	2	2017-07-13 20:32	2,042
WHO: scaling for AUC ? WHO: Chapeau! WHO: Chapeau! WHO: Chapeau!	Ohlbe	2017-06-12 13:29	3	2017-06-13 09:28	3,037
Calculation of Group effect for FDA studies Calculation of Group effect for FDA studies	GM	2017-06-09 08:10	1	2017-06-09 09:58	1,946

Bioequivalence and Bioavailability Forum 16:20 CEST