Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
EMA: What do I need if I wan to run an overdose study	jag009	2020-01-28 20:12	0		5
Statistical evaluation and BE hypotheses in full replicate design	Elena777	2020-01-28 07:02	0		41
FDA: required BE between early phase and Phase 3 formulations? no BE between early phase and Phase 3 formulations no BE between early phase and Phase 3 formulations relax Thanks! FDA: required BE between early phase and Phase 3 formulations?	fno	2020-01-22 15:38	5	2020-01-27 20:06	273
Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission	Biostats	2020-01-24 08:19	0		118
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 14:35	5,283
Significance of Ctau,ss in steady state study Relevance of Cτ,ss	Biostats	2019-12-20 07:51	1	2019-12-20 12:46	569
biowaiver requirement for APAC (Asia Pacific)	jag009	2019-12-18 04:45	0		476
Informed Consent Document Review Informed Consent Document Review Informed Consent Document Review	suchit_bhavsar	2019-12-11 11:22	2	2019-12-11 19:36	704
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 18:53	2,084
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 18:15	862
Generic submission in India Dead silence in India Generic submission in India	jag009	2019-11-11 21:43	2	2019-12-09 13:29	2,230
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	2019-12-06 00:26	599
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 18:20	3,280
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 10:11	726
Furosemide oral tablet	Ibrahim Komeil	2019-11-18 09:03	0		451