Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Simulation of inter-subject variability in replicate study Simulation of inter-subject variability in replicate study Simulation of inter-subject variability in replicate study ABE for partial replicate design acc. to the FDA ABE for partial replicate design acc. to the FDA	Shuanghe	2025-12-14 17:35	4	2026-02-18 12:04	2,664
Partial replicate design extra-reference design extra-reference design extra-reference design: R code extra-reference design: R code extra-reference design: no period effect assumption extra-reference design: no period effect assumption	Silva	2013-12-31 12:17	6	2025-12-31 16:42	7,698
‘alpha’ of scaled ABE? ‘alpha’ of scaled ABE? ’alpha’ of scaled ABE: design N=24, 48 adaptive design without adjustment α adjustment? iteratively adjusted alpha throw away our sample size tables? if real regulators don’t care? adjusting α missing letter PowerTOST: sampleN.scABEL.ad() PowerTOST: sampleN.scABEL.ad() Molins et al. (2017) target α in sim’s? target α in sim’s? If it is real: results having alpha fixed swr fixed swr Yes but no but yes but no but…	d_labes	2013-03-15 15:56	21	2024-11-08 14:34	39,533
data management data management	Imph	2024-03-14 09:57	1	2024-03-14 15:47	4,942
homoscedasticity assumption in RSABE method heteroscedasticity in RSABE (and ABEL) heteroscedasticity in RSABE (and ABEL) homoscedasticity assumption in RSABE method Asking a pupil Asking a pupil	WinnieH	2023-08-18 08:57	5	2023-08-18 17:16	6,250
any SAS or R-macro for 3 period two sequence RSABEIs Use the one for TRTR \| RTRT RSABE R coded by Detlew ‘dlat’ for 3-period full replicate? ‘dlat’ for 3-period full replicate? Likely wrong workaround? a bit corrected workaround THX! Another attempt… complete.cases for dlat and ilat? a bit corrected workaround	Achievwin	2023-07-05 18:38	9	2023-07-10 20:43	8,418
Reference-Scaled Average Bioequivalence FDA: TRT\|RTR instead of TRR\|RTR\|RRT?	Brus	2023-06-06 12:18	1	2023-06-07 10:22	4,765
Upper confidence bound and confidence interval of RSABE	WinnieH	2023-03-21 10:58	0		3,341
Questions on understanding the 4-way RSABE method SAS code Questions on understanding the 4-way RSABE method SAS code Questions on understanding the 4-way RSABE method SAS code	WinnieH	2023-01-04 13:33	2	2023-01-04 15:12	5,924
scale average bioequivalence for parallel design Parallel design: Maybe (‼) in exceptional cases Parallel design: Maybe (‼) in exceptional cases	Mahmoud	2022-06-15 12:33	2	2022-06-15 21:26	5,462
Sample size and power	Helmut	2022-03-28 13:39	0		3,392
Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design NTIDs	Sereng	2022-01-28 19:37	3	2022-01-29 11:19	6,061
FDA: SAS-code for NTIDs FDA: SAS-code for NTIDs	Bebac user	2021-12-06 00:36	1	2021-12-06 09:55	5,779
Inter-subject variability in Full replicate design Inter-subject variability in Full replicate design Inter-subject variability in Full replicate design	MGR	2021-09-30 07:35	2	2021-09-30 13:25	6,481
If we have any methods to widen CI in parallel design with high variance drug? If we have any methods to widen CI in parallel design with high variance drug? If we have any methods to widen CI in parallel design with high variance drug?	libaiyi	2021-02-02 09:39	2	2021-02-02 10:40	5,605