Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	14,932
Thalidomide Thalidomide	Rosy	2019-02-19 23:09	1	2019-02-26 15:07	5,376
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	22,327
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	44,399
NTI Criteria Waiver	sury	2018-12-24 07:04	0		3,381
subject withdrawn after bioanalysis Cherry-picking? Cherry-picking?	anbu	2018-09-12 10:17	2	2018-09-12 11:17	6,898
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	7,459
Definition of Enrolled subject Definition of Enrolled subject Definition of Enrolled subject	jag009	2018-07-11 21:27	2	2018-07-17 04:36	5,910
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	7,962
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	6,447
Outlier in BE Low AUC after reference product Low AUC after reference product Outlier in BE Outlier in BE Outlier in BE	ramgopi	2018-03-14 11:29	5	2018-03-19 09:55	8,467
When the the infusion speed deviate from the protocol specified Different PK profile Different PK profile Different PK profile Different PK profile Suitable equipment? Suitable equipment? AUC=f·D/CL AUC=f·D/CL AUC=f·D/CL AUC=f·D/CL When the the infusion speed deviate from the protocol specified When the the infusion speed deviate from the protocol specified	ssussu	2018-02-06 10:48	12	2018-02-08 23:31	13,981
Ever handled the "wrong treatment" in a PK?	Relaxation	2018-01-26 18:31	0		3,540
risk management	Norah	2018-01-22 13:53	0		2,988
ULOQ ULOQ ULOQ ULOQ ULOQ Not excluding invalid data? Excluding invalid data ULOQ Serial dilutions? Don’t!	Anand	2017-10-30 06:38	8	2017-10-30 17:03	12,040