Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Venetoclax film-coated tablets study requirement Venetoclax film-coated tablets study requirement	Regulatives / Guidelines	gsrao2022	2026-01-16 16:21	1	2026-02-02 08:46	1,413
PBE Calculations when Number of Containers per Batch is Not Uniform PBE Calculations when Number of Containers per Batch is Not Uniform PBE Calculations when Number of Containers per Batch is Not Uniform PBE Calculations when Number of Containers per Batch is Not Uniform	General Statistics	studious_117	2026-01-26 20:35	3	2026-01-27 21:47	1,414
Dosing of oral sprinkle granules Dosing of oral sprinkle granules Dosing of oral sprinkle granules	Design Issues	Loky do	2025-12-04 18:54	2	2026-01-22 08:52	1,809
AUCinfinity BE requirement for Mexico and Brazil IR or MR? IR or MR?	Regulatives / Guidelines	jag009	2026-01-20 16:52	2	2026-01-21 18:19	1,483
Repeat BE only for failed analyte	Study Assessment	qualityassurance	2026-01-16 12:52	0		852
Partial replicate design extra-reference design extra-reference design extra-reference design: R code extra-reference design: R code extra-reference design: no period effect assumption extra-reference design: no period effect assumption	RSABE / ABEL	Silva	2013-12-31 12:17	6	2025-12-31 16:42	7,588
Robustness of bioequivalence when 90%CI doesn’t include 1 statistical significance ≠ clinical relevance statistical significance ≠ clinical relevance Δ (20% in general)	Study Assessment	Darborn	2025-12-23 08:55	3	2025-12-24 09:59	1,924
Zonisamide Concentration in human Serum	Bioanalytics	shreyas goswami	2025-12-15 05:52	0		1,205
Carry over and statistical adjustment in BE computations Carry-over → 🚮 Carry-over → 🚮 Carry-over → 🚮 Carry-over Carry-over Carry-over Carry-over Carry-over more than 20% subject carry over effect investigation carry over effect investigation based on what? carry over effect investigation based on what? Carry-over → 🚮 Carry-over → 🚮 Carry-over → 🚮 Outdated and wrong answers Wrong answer	General Statistics	Achievwin	2023-10-02 20:34	16	2025-12-11 05:11	14,577
Data for MSc Thesis on Bioequivalence Data for MSc Thesis on Bioequivalence Data for MSc Thesis on Bioequivalence Data for MSc Thesis on Bioequivalence Data for MSc Thesis on Bioequivalence	General Statistics	Obinoscopy	2025-12-07 14:59	4	2025-12-10 11:13	2,297
Deferasirox fast study	Regulatives / Guidelines	mokhtar saleh	2025-12-04 18:52	0		1,146
ICH M12 Drug Interaction Studies: Determination of No-Effect Boundaries Filgotinib DDI? Filgotinib DDI?	Regulatives / Guidelines	BEQool	2025-11-26 11:58	2	2025-12-02 14:09	2,043
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	Regulatives / Guidelines	jag009	2025-11-19 20:29	5	2025-11-23 22:37	2,800
EMA: Draft GL on non-inferiority and equivalence	BE/BA News	Helmut	2025-11-17 10:05	0		1,354
Visual inspection of fits (estimation of λ-z) Visual inspection of fits (estimation of λ-z) Wetware 🧠 vs. software 🤖 Manual integrations Manual int	NCA / SHAM	Helmut	2025-11-15 12:36	4	2025-11-17 09:35	2,314