Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
BEQ inquiry from health authority BEQ inquiry from health authority Method not sensitive enough Revalidation? Revalidation? Method not sensitive enough Method not sensitive enough Method not sensitive enough	Study Assessment	Aymanmy	2019-12-18 08:51	7	2019-12-19 08:21	1,035
Question：Using Phoenix WinNonlin Crossover object for Tmax test Phoenix WinNonlin Crossover object for Tmax test Phoenix WinNonlin Crossover object for Tmax test Tmax Hypothesis testing Tmax Hypothesis testing neglecting periods for Tmax Tmax Hypothesis testing SAP? Tmax Hypothesis testing Tmax Hypothesis testing	Nonparametrics	0521	2018-11-09 07:02	9	2019-12-18 16:55	4,631
biowaiver requirement for APAC (Asia Pacific)	Regulatives / Guidelines	jag009	2019-12-18 04:45	0		539
Possible Excel bug? Possible Excel bug? Possible Excel bug? Possible Excel bug? M$: It’s not a bug, it’s a feature! M$: It’s not a bug, it’s a feature! M$: It’s not a bug, it’s a feature!	Software	Shuanghe	2019-12-17 13:01	6	2019-12-17 16:00	887
NTI drug but with high CV NTI drug with high CV?	Power / Sample Size	Mikalai	2019-12-14 15:39	1	2019-12-14 16:11	780
Informed Consent Document Review Informed Consent Document Review Informed Consent Document Review	Regulatives / Guidelines	suchit_bhavsar	2019-12-11 11:22	2	2019-12-11 19:36	826
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	Regulatives / Guidelines	Beholder	2019-11-08 07:51	10	2019-12-10 18:53	2,332
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 ?	Regulatives / Guidelines	jag009	2019-12-06 16:19	8	2019-12-09 18:15	1,075
Generic submission in India Dead silence in India Generic submission in India	Regulatives / Guidelines	jag009	2019-11-11 21:43	2	2019-12-09 13:29	2,340
To Russia (with love?) To Russia (with love?) From Russia (with love?) From Russia with review From Russia (with love?) Ignorance is not bliss Ignorance is not bliss Ignorance is not bliss - but this is modus vivendi Ignorance is Strength? So sad! does existence exist? OT: Something and nothing add OT: Everything and Nothing OT: Something and nothing Russian edition OT: Something and nothing Russian edition OT: “Deutscher Humor” OT: “Deutscher Humor” OT: “Deutscher Humor” OT: “Deutscher Humor” OT: Something and nothing	RSABE / ABEL	Helmut	2019-12-04 01:21	19	2019-12-07 21:21	1,638
Active metabolites: to measure or not to measure Active metabolites: to measure or not to measure Parent only. Chiral assay?	Regulatives / Guidelines	Elena777	2019-12-05 20:34	2	2019-12-06 00:26	703
A stray thought, just one of many	Power / Sample Size	ElMaestro	2019-12-05 18:01	0		306
ICH M13 ICH M13 ICH pushed by GBHI? ICH pushed by GBHI? “Lively” discussions M9 step 4 now published And Japan? And Japan? 🈴 business as usual	BE/BA News	Helmut	2019-11-27 19:08	8	2019-12-04 15:42	1,518
EMA Q&A vs EMA Product Specific guideline Crushed Rivaroxaban? Crushed Rivaroxaban? specific BE study with administration of crushed/disintegrated tablet	Regulatives / Guidelines	Averroes	2017-10-04 12:01	3	2019-12-03 18:20	3,408
Bio-waiver of Sapropterin dihydrochloride powder for oral solution Please do your homework first Bio-waiver of Sapropterin dihydrochloride powder for oral solution	Dissolution / BCS / IVIVC	AB661	2019-11-22 17:49	2	2019-12-03 17:06	1,071