Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
⚠️ Error 406 (in posting or replying) 📌	Tips / Tricks	Helmut	2022-10-29 17:00	0		17,857
Requesting data for a publication 📥 ♻️ 🚀 📌	General Statistics	Helmut	2023-02-23 10:46	0		16,524
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		173,374
ICH M13A & FDA Bioequivalence Guideline about missing data	Regulatives / Guidelines	kimhuang	2026-06-15 06:33	0		141
New FDA guidances	Regulatives / Guidelines	Ohlbe	2026-06-01 17:04	0		421
My first and failed attempt into AI code: Who can do it? mittyri can do it! Something missing? Something missing? A slight improvement Remoulade Tartar sauce Tartar sauce	🇷 for BE/BA	ElMaestro	2026-05-27 10:22	7	2026-05-31 11:43	1,208
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 🤔	Regulatives / Guidelines	Martynkf	2026-05-12 13:23	10	2026-05-25 17:13	1,809
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	Regulatives / Guidelines	jag009	2026-05-18 06:23	5	2026-05-22 16:49	1,097
SGS Exprimo	PK / PD	jag009	2026-05-06 20:38	0		480
ANVISA: Q&A of March 2026 A case of whatifitis ? Yessir! Sim’s and real data…	BE/BA News	Helmut	2026-04-29 13:02	2	2026-05-01 14:19	1,053
Single study with two different RLD / Submission Single study with two different RLD / Submission	Regulatives / Guidelines	Pharma_88	2026-04-30 04:46	1	2026-04-30 08:50	847
wilcox.text()	🇷 for BE/BA	Helmut	2026-04-26 09:44	0		640
FDA/CDER. Warning Letter: April 2, 2026	GxP / QC / QA	Helmut	2026-04-24 09:15	0		684
Amoxicillin powder for suspension 125 mg/5ml and 250 mg/5ml BE studies for Canada ICH M13A implemented in Canada	Regulatives / Guidelines	bebacrk	2026-04-14 08:25	1	2026-04-15 11:31	1,003
appropriate test for comparing Time values Comparing Time values: How? Duno. appropriate test for comparing Time values appropriate test for comparing Time values appropriate test for comparing Time values	General Statistics	Achievwin	2026-03-24 16:11	4	2026-03-26 22:02	2,707