Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
New FDA guidances	Ohlbe	2026-06-01 17:04	0		116
Sample size with theta0 < 0.95: any regulatory pushback? Sample size with theta0 < 0.95: Why not? Repeating Studies Buongiorno, signor Bonferroni! Buongiorno, signor Bonferroni! Sample size with theta0 < 0.95: any regulatory pushback? Sample size with theta0 < 0.95: any regulatory pushback? More information, please More information, please Still 🤔 Still 🤔	Martynkf	2026-05-12 13:23	10	2026-05-25 17:13	1,214
Dataset requirement for UK and EU Dataset requirement for UK and EU Dataset requirement for UK and EU Dataset requirement for UK and EU Dataset requirement for UK and EU Inf File	jag009	2026-05-18 06:23	5	2026-05-22 16:49	715
Single study with two different RLD / Submission Single study with two different RLD / Submission	Pharma_88	2026-04-30 04:46	1	2026-04-30 08:50	667
Amoxicillin powder for suspension 125 mg/5ml and 250 mg/5ml BE studies for Canada ICH M13A implemented in Canada	bebacrk	2026-04-14 08:25	1	2026-04-15 11:31	830
NDA and ANDA Bio study NDA and ANDA Bio study NDA and ANDA Bio study	NK	2026-03-13 06:26	2	2026-03-20 06:18	1,389
Bioequivalence concluded only in AUC Bioequivalence concluded only in AUC	Brus	2026-02-25 13:39	1	2026-02-26 08:44	1,169
Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product	A.Shtaiwi	2026-02-02 08:32	1	2026-02-18 07:04	1,188
is open label study acceptable for Canada after implementation of ICH M13A HC: open label studies acc. to ICH M13A HC: open label studies acc. to ICH M13A HC: outliers in replicate designs?	bebacrk	2026-02-12 05:14	3	2026-02-13 10:33	1,380
Venetoclax film-coated tablets study requirement Venetoclax film-coated tablets study requirement	gsrao2022	2026-01-16 16:21	1	2026-02-02 08:46	1,325
AUCinfinity BE requirement for Mexico and Brazil IR or MR? IR or MR?	jag009	2026-01-20 16:52	2	2026-01-21 18:19	1,399
Deferasirox fast study	mokhtar saleh	2025-12-04 18:52	0		1,111
ICH M12 Drug Interaction Studies: Determination of No-Effect Boundaries Filgotinib DDI? Filgotinib DDI?	BEQool	2025-11-26 11:58	2	2025-12-02 14:09	1,981
Question about ICH M13a Question about ICH M13a Question about ICH M13a Question about ICH M13a ICH M13A if >2 treatments ICH M13A if >2 treatments	jag009	2025-11-19 20:29	5	2025-11-23 22:37	2,718
ICHM13A/Multiple Test Product Studies α-adjustments? α-adjustments? α-adjustments? Beyond Bonferroni…	Mikkabel	2025-11-04 09:46	4	2025-11-10 08:56	2,325