Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
EU Transdermal Patch: Generic Submission	HallaGulla	2023-03-08 08:58	0		1,009
Documentation of SS for LAI Documentation of SS for LAI	Achievwin	2023-02-06 13:40	1	2023-02-28 16:50	1,748
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	2,299
Initial dose and design issues abridged submission daily ER vs BID IR	alejandro_jo1990	2022-09-15 15:35	0		1,449
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	4,948
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	2,597
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	2,374
‘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	2,739
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	2,308
PK time points PK time points	Vaibhav	2022-06-23 21:31	1	2022-06-24 09:29	1,461
Hydrocortisone BE studies for UK	HallaGulla	2022-05-16 17:37	0		1,349
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	1,807
With food administration With food administration	SerhiiP	2022-01-20 09:20	1	2022-01-20 10:49	1,832
ODT in BE study ODT in BE study	Farmacevt	2022-01-18 16:01	1	2022-01-18 18:08	1,685
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	6,432