Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
CVwithin calculation of biperiden pooled CV from MR vs. IR pooled CV from MR vs. IR pooled CV from MR vs. IR pooled CV from MR vs. IR TSD: BE in stage 1 TSD: BE in stage 1	CECIF	2018-01-17 20:44	6	2018-01-21 02:32	7,359
Why is the bootstrap not widely used?	ElMaestro	2018-01-13 11:06	0		2,832
IntraCV calculation IntraCV calculation IntraCV calculation IntraCV calculation IntraCV calculation IntraCV calculation	youivab	2017-12-27 06:20	5	2017-12-28 05:56	8,368
T/R ratio for estimation of sample size in BE study of NTI drugs T/R ratio for estimation of sample size in BE study of NTI drugs T/R ratio for estimation of sample size in BE study of NTI drugs T/R ratio for estimation of sample size in BE study of NTI drugs Defaults in PowerTOST	mahmoud-teaima	2017-10-24 19:18	4	2017-10-26 12:49	10,892
T/R ratio and the content of the active compound in each product assumed (!) T/R ratio assumed (!) T/R ratio	CECIF	2017-10-11 18:18	2	2017-10-11 18:35	7,294
Pivotal BE trial power not enough to 0.8 Pivotal BE trial power not enough to 0.8 Pivotal BE trial power not enough to 0.8	ssussu	2017-09-22 07:40	2	2017-09-22 07:21	6,426
Sample size for FDA's in vitro population BE Extra-marital cohabitation The hidden details The hidden details Sample size for FDA's in vitro population BE Sample size for FDA's in vitro population BE Sample size for FDA's in vitro population BE	ElMaestro	2017-09-08 17:24	6	2017-09-11 11:26	11,561
CVintra for Cmax > AUC, therefore use AUC for sample size? CVintra for Cmax > AUC, therefore use AUC for sample size? CVintra for Cmax > AUC, therefore use AUC for sample size? Crap… Crap… CVintra for Cmax > AUC, therefore use AUC for sample size? CVintra for Cmax > AUC, therefore use AUC for sample size? CVintra for Cmax > AUC, therefore use AUC for sample size? CVintra for Cmax > AUC, therefore use AUC for sample size?	nobody	2017-08-07 17:14	8	2017-08-09 15:11	12,418
How to create table of results How to create table of results How to create table of results How to create table of sample sizes / powers How to create table of sample sizes / powers Symmetrical in log-scale Symmetrical in log-scale RTFM	BE-proff	2017-07-20 14:09	7	2017-07-24 16:18	11,584
Estimation within-subject CV Estimation within-subject CV CVwR ~ CVwT ~ CVw? CVwR ~ CVwT ~ CVw? CVwR = CVwT < CVw‽ 'whatif' plotting from 4X2 to 2X2 CVwR ~ CVwT ~ CVw? CVwR ~ CVwT ~ CVw?	Mikkabel	2017-07-07 10:13	7	2017-07-09 00:13	10,505
Assumptions for powering a XO study CVintra ≠ CVtotal	Laura R	2017-06-01 14:57	1	2017-06-01 13:47	5,594
Sample Size calculation and setting of BE limit base on Cmax or AUC PK metric with largest variability – generally – drives the sample size Regulatory guidance versus literature data FDA: If RSABE not recommended in product-specific guidance FDA: If RSABE not recommended in product-specific guidance	mahmoud-teaima	2017-05-22 13:55	4	2017-05-23 14:20	7,570
Canada: Sample size for Cmax? Canada: IUT violated? Canada: IUT violated? IUT Canada: Sample size for Cmax: R-code? Canada: Sample size for Cmax: R-code? HC: Sample size for AUC and Cmax: exact and sim’s HC: Sample size for AUC and Cmax: exact and sim’s	Helmut	2012-12-18 18:04	7	2017-01-31 12:44	13,800
Sample size justification Post hoc sample size “justification”	rajasekhar	2017-01-20 09:54	1	2017-01-20 10:59	5,619
Expected Power	Ben	2016-12-29 14:15	0		4,295