Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission	Biostats	2020-01-24 08:19	0		2,731
Bioequivalence of racemic drugs using non-steriospecific bio BE of racemic drugs (EMA vs. FDA) BE of racemic drugs (EMA vs. FDA) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice)	scorp2011	2012-01-12 13:21	6	2019-12-30 13:35	10,297
Significance of Ctau,ss in steady state study Relevance of Cτ,ss	Biostats	2019-12-20 07:51	1	2019-12-20 11:46	5,430
biowaiver requirement for APAC (Asia Pacific)	jag009	2019-12-18 04:45	0		2,597
Informed Consent Document Review Informed Consent Document Review Informed Consent Document Review	suchit_bhavsar	2019-12-11 11:22	2	2019-12-11 18:36	4,548
Clarification from Russian expert organization regarding telmisartan BE studies Clarification from Russian expert organization… Questions Guesses & answers intergender differences and consequences intergender differences and no consequences Questions Questions Careful Confusion from Russian expert organization Clarification from Russian expert organization regarding telmisartan BE studies	Beholder	2019-11-08 07:51	10	2019-12-10 17:53	9,607
NDA study for Mexico Cmax ER = Cmax IR ? Cmax ER = Cmax IR - the only option Cmax ER = Cmax IR - the only option Cmax ER = Cmax IR ? Cmax ER = Cmax IR ? Cmax ER = Cmax IR ? Cmax ER = Cmax IR ? Cmax ER = Cmax IR ?	jag009	2019-12-06 16:19	8	2019-12-09 17:15	6,698
Generic submission in India Dead silence in India Generic submission in India	jag009	2019-11-11 21:43	2	2019-12-09 12:29	5,787
Active metabolites: to measure or not to measure Active metabolites: to measure or not to measure Parent only. Chiral assay?	Elena777	2019-12-05 20:34	2	2019-12-05 23:26	4,350
EMA Q&A vs EMA Product Specific guideline Crushed Rivaroxaban? Crushed Rivaroxaban? specific BE study with administration of crushed/disintegrated tablet	Averroes	2017-10-04 12:01	3	2019-12-03 17:20	8,386
necessity of retention samples for pilot BE study necessity of retention samples for pilot BE study necessity of retention samples for pilot BE study necessity of retention samples for pilot BE study necessity of retention samples for pilot BE study necessity of retention samples for pilot BE study	Shuanghe	2019-11-25 13:05	5	2019-11-26 09:11	7,410
Furosemide oral tablet	Ibrahim Komeil	2019-11-18 09:03	0		2,439
IS response variations IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations Not more on IS response variations Not more on IS response variations the run passes = there is no problem? the run passes = there is no problem?	Ohlbe	2019-09-04 19:03	14	2019-11-13 18:17	10,073
Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet	Nidhiya J S	2019-11-05 06:14	4	2019-11-11 09:51	6,471
standby and retention samples standby and retention samples standby and retention samples Reserve samples? Spare subjects? Spare subjects? Spare subjects? standby and retention samples	zeynep	2019-10-24 12:22	7	2019-10-30 10:31	6,497