Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Subject non compliance Subject non compliance (or product failure?) Subject non compliance (or product failure?) Bad science (statistics is taboo) unexpected behavior for test product Subject-by-Formulation interaction? Subject-by-Formulation interaction?	Loky do	2020-07-15 12:57	6	2020-07-26 11:30	684
Missing concentration Missing concentration	shahajan baig	2020-07-06 01:15	1	2020-07-13 13:51	595
Regarding used normal Two-way crossover program was used for un-scaled average (2×2×2?) ANOVA instead of mixed model	Sivakrishna	2020-06-01 11:47	1	2020-06-01 15:08	662
Outlier in BE study Outlier in BE study Outlier in BE study Outlier in BE study Missing samples Missing samples Missing samples Missing samples Options Options	Amira Gouda	2020-04-28 15:36	9	2020-05-03 21:15	3,952
Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective	Brus	2020-03-27 17:22	4	2020-04-06 19:41	1,224
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	wienui	2020-01-05 18:22	5	2020-01-28 20:16	3,110
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	Aymanmy	2019-12-18 08:51	7	2019-12-19 08:21	2,020
Impact of Parenteral hydration in a BE study Violation of GCP‽ Impact of Parenteral hydration in a BE study Impact of Parenteral hydration in a BE study	Cec75	2019-11-15 16:39	3	2019-11-19 16:03	2,059
NTI drug Bioequivalence study Statistical approach Cherry-picking? digging out the possible reasons of the failure Fed state: T higher variable than R	Sukalpa Biswas	2019-08-06 09:15	3	2019-08-09 12:36	2,110
Call me stupid if you think so... Call me stupid if you think so... Call me stupid if you think so... Call me stupid if you think so...	jag009	2019-07-27 04:43	3	2019-07-28 21:58	1,565
Good News, Bad News Good News only Good News only, but not according to some ’Some’ should read the GL (and again, and again) Good News only, but not according to some My stuff My stuff My stuff ≡ Sequence effect Vs Subject effect? Sequence effect Vs Subject effect? Sequence effect Vs Subject effect? Oops!	Datacollector	2019-07-27 12:09	12	2019-07-28 16:36	3,597
In-vitro microbial kill rate study In-vitro microbial kill rate study	kumarnaidu	2019-04-26 10:31	1	2019-04-26 11:07	1,583
SAS code for the mixed effects model with sequence mistakenly assigned Failure in randomization Real sensitivity What is your root cause?	libaiyi	2019-04-19 09:32	3	2019-04-19 16:19	1,821
Clinical end point acceptance limit Clinical end point acceptance limit Clinical end point acceptance limit Clinical end point acceptance limit –0.2025 < –0.2, right?	PKS	2019-04-05 08:45	4	2019-04-05 10:53	2,091
Carry-over in pre-dose samples for steady state BE Carry-over in pre-dose samples for steady state BE 5% Cmax-rule only in SD 5% Cmax-rule only in SD Carry-over in pre-dose samples for steady state BE	hirenpharm	2019-03-29 20:56	4	2019-04-03 02:48	2,481