Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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 19:15	8,446
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 17:41	4,114
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 19:16	7,000
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 07:21	6,056
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 15:03	4,790
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 10:36	6,659
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 19:58	4,375
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 14:36	9,360
In-vitro microbial kill rate study In-vitro microbial kill rate study	kumarnaidu	2019-04-26 10:31	1	2019-04-26 09:07	4,635
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 14:19	4,991
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 08:53	5,161
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 00:48	5,911
BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax FDA and outliers BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax regulatory reasons to consider the study inadequate Good question, next question first point Cmax: trouble waiting to happen?	Mann	2018-12-09 10:14	10	2019-03-03 20:42	11,713
Thalidomide Thalidomide	Rosy	2019-02-19 23:09	1	2019-02-26 15:07	4,047
CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? PowerTOST: CVfromCI PowerTOST: CVfromCI -> CI.BE Oops! Oops! df? Oops! df? Oops! df! Oops! df? Oops! df? All the answers are here PowerTOST: CVfromCI type known.designs() in PowerTOST type known.designs() in PowerTOST	Elena777	2018-01-20 12:31	22	2019-02-21 13:49	17,571