Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		97,407
The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time	Study Assessment	wienui	2020-01-05 18:22	5	2020-01-28 20:16	509
EMA: What do I need if I wan to run an overdose study	Regulatives / Guidelines	jag009	2020-01-28 20:12	0		33
R in regulated environments FDA, again R in regulated environments R in regulated environments internal tools and modelling	R for BE/BA	Helmut	2019-08-28 14:58	4	2020-01-28 16:00	1,195
Statistical evaluation and BE hypotheses in full replicate design	Regulatives / Guidelines	Elena777	2020-01-28 07:02	0		56
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?	Regulatives / Guidelines	fno	2020-01-22 15:38	5	2020-01-27 20:06	277
Higher-order crossovers Purpose of the study? Higher-order crossovers	Power / Sample Size	sweiner	2020-01-22 20:22	2	2020-01-26 16:50	304
Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission	Regulatives / Guidelines	Biostats	2020-01-24 08:19	0		127
What are we doing here? What are we doing here? What are we doing here? What are we doing here?	Off Topic	nobody	2020-01-20 10:20	3	2020-01-20 16:23	265
Sample size calculations Sample size calculations Sample size calculations	Power / Sample Size	GM	2020-01-17 13:42	2	2020-01-20 06:59	286
Steady State Bioequivalence Study Pre-dose samples	Design Issues	Pharma_88	2020-01-08 10:07	1	2020-01-09 12:36	451
3+3 Design 3+3 Design 3+3 Design Subject replacement Dose escalation and DMC Dose escalation and DMC	Design Issues	Pharma_88	2020-01-07 08:09	5	2020-01-08 10:41	473
Normal Reference Range Vs Pre-defined site normal values Normal Reference Range Vs Pre-defined site normal values Hb level OT Hb level Hb level Hb level Hb level Hb level Participation databases Participation databases Participation databases Participation databases Participation databases Participation databases National databases‽ Great discussion Great discussion Great discussion WTF 😡 Great discussion National databases‽	Design Issues	cakhatri	2019-12-17 11:35	21	2020-01-02 18:42	1,449
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)	Regulatives / Guidelines	scorp2011	2012-01-12 13:21	6	2019-12-30 14:35	5,292
Group by sequence interaction Group by sequence interaction, an urban myth? pristine, genuine, holy, magnificent, inexplicable beautiful variation I love your subject line! Group effect, did you miss it? Group effect, did you miss it? Group effect: the endless story Group effect: the endless river Group effect: the endless river replicateBE solution with interactions replicateBE solution with interactions datasets issues datasets datasets lmer / lme What do you mean exactly? What do you mean exactly? ANOVA acc. to GL	General Statistics	Mutasim	2019-08-07 13:16	17	2019-12-30 12:32	2,544