Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Marginally failed study for Europe Marginally failed study for Europe Upper 90% CL 0.17% > U	balakotu	2018-04-24 07:30	2	2018-04-29 21:46	6,492
BE/BA centers BE/BA centers BE/BA centers BE/BA centers BE/BA centers BE/BA centers	JLpiccard	2018-07-13 20:35	5	2018-07-16 16:51	8,012
Definition of Enrolled subject Definition of Enrolled subject Definition of Enrolled subject	jag009	2018-07-11 21:27	2	2018-07-17 04:36	5,964
Cmax is out of the range Bad luck Bad luck Cherry-picking Cmax is out of the range	Mikalai	2018-08-01 12:05	4	2018-08-02 15:56	7,506
subject withdrawn after bioanalysis Cherry-picking? Cherry-picking?	anbu	2018-09-12 10:17	2	2018-09-12 11:17	6,935
NTI Criteria Waiver	sury	2018-12-24 07:04	0		3,391
Dose Proportionality and Variance More information, please More information, please Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Phoenix 64 Warning Phoenix 64 Warning OT: imperial vs. metric units Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin NCSS vs. PHX/WNL vs. SAS NCSS vs. PHX/WNL vs. SAS - Validation? Diagnostics Diagnostics: R and Phoenix Diagnostics: R Diagnostics: R SASian potpourri Compilation REML or not complete or not Compilation doubts about NCSS Doubts about NCSS Compilation Kenward-Roger? 90% confidence interval for R_dnm 90% confidence interval for R_dnm Visualizing lmer and limits Visualizing lmer and limits Visualizing lmer and limits Visualizing lmer and limits 90% confidence interval for R_dnm 90% confidence interval for R_dnm 90% confidence interval for R_dnm 90% confidence interval for R_dnm offtop: greek letters and tables OT: greek letters and symbols Smith’s paper Smith’s paper	AngusMcLean	2016-05-11 16:55	41	2019-02-02 15:04	44,591
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	22,449
Thalidomide Thalidomide	Rosy	2019-02-19 23:09	1	2019-02-26 15:07	5,418
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	15,066
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	7,972
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	7,111
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	6,818
In-vitro microbial kill rate study In-vitro microbial kill rate study	kumarnaidu	2019-04-26 10:31	1	2019-04-26 09:07	6,301
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	12,706