Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	Sereng	2023-03-13 17:08	12	2023-03-28 09:03	590
EU Transdermal Patch: Generic Submission	HallaGulla	2023-03-08 08:58	0		202
Documentation of SS for LAI Documentation of SS for LAI	Achievwin	2023-02-06 13:40	1	2023-02-28 16:50	586
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	871
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…	Imph	2022-09-25 13:52	6	2022-10-25 09:21	1,593
Initial dose and design issues abridged submission daily ER vs BID IR	alejandro_jo1990	2022-09-15 15:35	0		787
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	3,102
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	1,518
Drug-drug interaction with two different route of administration Drug-drug interaction with two different route of administration Drug-drug interaction with two different route of administration Drug-drug interaction with two different route of administration Drug-drug interaction with two different route of administration Drug-drug interaction with two different route of administration Drug-drug interaction with two different route of administration Interpreting results of a DDI study	Mr.Rao	2022-07-13 13:51	7	2022-07-27 07:52	1,261
‘Two-at-a-Time’ approach with >3 treatments ‘Two-at-a-Time’ approach with >3 treatments ‘Two-at-a-Time’ approach with >3 treatments ‘Two-at-a-Time’ approach with >3 treatments ‘Two-at-a-Time’ approach; ≥3 treatments: new 🇷 script ‘Two-at-a-Time’ approach; ≥3 treatments: new 🇷 script You’re a NE🇷D!	Helmut	2022-06-12 11:37	6	2022-07-13 14:46	1,534
BE study Design for Rivaroxaban 20 mg Rivaroxaban: FDA and others Rivaroxaban: FDA and others Rivaroxaban: FDA and others Rivaroxaban: FDA and others	Tricky TAB	2022-07-04 11:33	4	2022-07-06 04:52	1,257
PK time points PK time points	Vaibhav	2022-06-23 21:31	1	2022-06-24 09:29	715
Switchability with replicate design studies Switchability = IBE Switchability = IBE S × F interaction S × F interaction	Achievwin	2022-05-20 04:44	4	2022-05-20 21:32	839
Hydrocortisone BE studies for UK	HallaGulla	2022-05-16 17:37	0		807
Coefficient variation intra subject variability of librax Coefficient variation intra subject variability of librax Coefficient variation intra subject variability of librax	Bebac user	2022-02-17 19:31	2	2022-03-05 11:56	1,026