Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Amlodipine/Valsartan Amlodipine/Valsartan Amlodipine/Valsartan Amlodipine/Valsartan Amlodipine/Valsartan Use all data and avoid the partial replicate design for the FDA	Bebac user	2023-09-09 06:34	5	2023-12-07 09:01	4,301
Ebastine study design Ebastine study design	Bebac user	2023-11-25 13:07	1	2023-11-27 09:53	3,175
Adhesion Score Analysis	durga09	2023-07-17 11:15	0		2,213
Stabilization period Stabilization period Stabilization period	Vismayi	2023-06-26 19:55	2	2023-06-30 15:13	2,863
SD crossover study with no washout any examples SD crossover study with no washout any examples SD crossover study with no washout any examples	Achievwin	2023-06-19 16:37	2	2023-06-20 14:48	2,791
Switchability with replicate design studies Switchability = IBE Switchability = IBE S × F interaction S × F interaction S × F interaction S × F interaction S × F interaction	Achievwin	2022-05-20 04:44	7	2023-06-08 10:21	4,372
Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ If you have data… If you have data… Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½	Imph	2022-09-25 13:52	9	2023-05-27 08:36	5,711
Inclusion criteria in BE studies BE: ♀♂ Inclusion criteria in BE studies Stratify for sex? Stratify for sex? Inclusion criteria in BE studies Inclusion criteria in BE studies Inclusion criteria in BE studies Sex-by-treatment interaction Sex-by-treatment interaction	Loky do	2020-05-22 18:16	9	2023-05-11 09:12	7,788
Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Definition of Full Replicate Full Replicate with 3 periods Full Replicate with 3 periods Full Replicate with 3 periods Definition of Full Replicate Replicate Design ≠ Higher-Order Crossover Thank You! Replicate Design ≠ Higher-Order Crossover imbalance in Latin Square Balance for all effects	Sereng	2023-03-13 17:08	13	2023-04-21 10:01	5,878
EU Transdermal Patch: Generic Submission	HallaGulla	2023-03-08 08:58	0		1,904
Documentation of SS for LAI Documentation of SS for LAI	Achievwin	2023-02-06 13:40	1	2023-02-28 16:50	3,050
Study Design: Two treatment or Four treatment Study Design: Two treatment or Four treatment Study Design: Two treatment or Four treatment Study Design: Two treatment or Four treatment Study Design: Two treatment or Four treatment	NK	2023-01-23 09:38	4	2023-01-24 03:37	3,979
Initial dose and design issues abridged submission daily ER vs BID IR	alejandro_jo1990	2022-09-15 15:35	0		2,279
Bioequivalence of mirabegron 50 mg extended release Tablet Replicate designs based on information of 2×2×2 design Replicate designs based on information of 2×2×2 design Assumption of authority? Bioequivalence of mirabegron 50 mg extended release Tablet Bioequivalence of mirabegron 50 mg extended release Tablet	Ibrahim Komeil	2021-02-20 11:36	5	2022-08-04 13:47	7,977
Could we design the RCT as a non-inferiority trial at this situation? Non-Superiority Non-Superiority Non-Superiority Non-Superiority Placebo effect Could we design the RCT as a non-inferiority trial at this situation? Could we design the RCT as a non-inferiority trial at this situation?	dennis001	2022-07-24 17:39	7	2022-07-27 10:17	4,707