Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
multiple dose studies multiple dose studies Css level?	Loky do	2024-01-21 16:15	2	2024-01-26 10:03	5,386
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	5,096
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	5,069
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	7,998
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	8,334
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	7,960
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	4,935
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	7,220
Non-accuracy and precision validation runs as per M10 guideline	avinash	2023-07-27 13:16	0		3,296
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	5,610
Sensitization test	Kelen	2023-06-30 13:13	0		2,892
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	4,638
Data analysis and sample size for replicate study designs as per recent FDA guidance	balakotu	2023-05-23 12:16	0		3,097
regulatory guideline	wock	2023-05-22 06:06	0		3,113
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	5,199