Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	922
Initial dose and design issues abridged submission daily ER vs BID IR	alejandro_jo1990	2022-09-15 15:35	0		451
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	2,587
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	1,227
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	916
‘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	1,212
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	864
PK time points PK time points	Vaibhav	2022-06-23 21:31	1	2022-06-24 09:29	506
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	599
Hydrocortisone BE studies for UK	HallaGulla	2022-05-16 17:37	0		655
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	802
With food administration With food administration	SerhiiP	2022-01-20 09:20	1	2022-01-20 10:49	942
ODT in BE study ODT in BE study	Farmacevt	2022-01-18 16:01	1	2022-01-18 18:08	856
Biosimilars Biosimilars Biosimilars Healthy subjects vs. patients Biosimilars Biosimilars Biosimilars Biosimilars Biosimilars Biosimilars	M.Vasu	2011-11-24 14:01	9	2021-10-22 05:53	5,498
EU: Fed or fasting conditions for BE study EU: Fed state according to the reference’s SmPC EU: Fed state according to the reference’s SmPC	Farmacevt	2021-09-24 15:47	2	2021-09-27 19:44	1,211