Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
ICH M10 - Method validation - Anchoring points-reg ICH M10 - Method validation - Anchoring points-reg LBAs: Anchor points and model fitting LBAs: Anchor points and model fitting	ryraman2661	2024-03-20 04:51	3	2024-03-25 12:28	802
Tmax guideline The minefield…	Laura Carreiras	2024-02-16 15:05	1	2024-02-16 15:59	826
multiple dose studies multiple dose studies Css level?	Loky do	2024-01-21 16:15	2	2024-01-26 10:03	922
Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) EMA: No AUC(0-72h) for all MR products	JP2030	2023-10-18 05:58	1	2023-10-18 07:09	1,514
Application and test region of vasoconstrictor assay Application and test region of vasoconstrictor assay	Kelen	2023-10-04 16:31	1	2023-10-17 09:34	1,460
Tmax 90% confidence interval Tmax 90% confidence interval link to the post of BEBAC golden collection link to the post of BEBAC golden collection CI for difference in Tmax Tmax problems	durga09	2023-09-08 10:21	5	2023-10-12 06:55	2,293
BCS class I (dispersible tablet): selection of reference product BCS class I (dispersible tablet): selection of reference product	yuva	2023-08-01 11:23	1	2023-08-01 12:36	1,626
Non-accuracy and precision validation runs as per M10 guideline	avinash	2023-07-27 13:16	0		1,210
Sensitization test	Kelen	2023-06-30 13:13	0		1,008
non-accuracy and precision validation runs in ICH M10 guideline Inaccuracy, precision acc. to IUPAC Inaccuracy, precision acc. to IUPAC non-accuracy and precision validation runs in ICH M10 guideline non-accuracy and precision validation runs in ICH M10 guideline	avinash	2023-06-30 09:28	4	2023-07-28 05:25	1,899
SFDA BE GL v3.1 (also GCC?) SFDA BE GL v3.1 (also GCC?) SFDA BE GL v3.1 (GCC reference?) SFDA BE GL v3.1 (also GCC?) SFDA BE GL v3.1 (also GCC)	Helmut	2023-06-23 08:55	4	2023-07-04 19:46	1,612
Including duplicates of Low, medium and High QCs during analytical method validation Including duplicates of Low, medium and High QCs during analytical method validation	Ayman Rabayah	2023-06-15 07:14	1	2023-06-15 08:36	1,263
Data analysis and sample size for replicate study designs as per recent FDA guidance	balakotu	2023-05-23 12:16	0		1,075
regulatory guideline	wock	2023-05-22 06:06	0		1,123
Design for the EMA BE for the EMA BE for the EMA BE for the EMA	ryraman2661	2023-05-15 13:03	3	2023-05-16 08:51	1,601