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	809
Tmax guideline The minefield…	Laura Carreiras	2024-02-16 15:05	1	2024-02-16 15:59	829
multiple dose studies multiple dose studies Css level?	Loky do	2024-01-21 16:15	2	2024-01-26 10:03	924
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	1,515
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	1,461
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	2,294
Test License Test License Test License Remaining RLDs from pilot study Remaining RLDs from pilot study Remaining RLDs from pilot study- retention sample?	rajasekharkakarla	2018-10-06 08:05	5	2023-10-03 17:27	3,358
Fed-fasted BE studies using different polymorphs Fed-fasted BE studies using different polymorphs Fed-fasted BE studies using different polymorphs Submission of 'failed' studies Submission of 'failed' studies Fed-fasted BE studies using different polymorphs	london12	2009-08-25 14:21	5	2023-08-03 10:44	4,055
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 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	1,900
Non-accuracy and precision validation runs as per M10 guideline	avinash	2023-07-27 13:16	0		1,210
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
Sensitization test	Kelen	2023-06-30 13:13	0		1,008
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	1,265
Data analysis and sample size for replicate study designs as per recent FDA guidance	balakotu	2023-05-23 12:16	0		1,075