Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
IntraCV calculation IntraCV calculation IntraCV calculation IntraCV calculation IntraCV calculation IntraCV calculation	youivab	2017-12-27 06:20	5	2017-12-28 05:56	6,717
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	9,039
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	5,872
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	5,245
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	10,038
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	10,810
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	9,867
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	8,889
Assumptions for powering a XO study CVintra ≠ CVtotal	Laura R	2017-06-01 14:57	1	2017-06-01 13:47	4,569
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	6,168
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	11,864
Sample size justification Post hoc sample size “justification”	rajasekhar	2017-01-20 09:54	1	2017-01-20 10:59	4,594
Expected Power	Ben	2016-12-29 14:15	0		3,484
Sample Size II Please see the answer to your previous post Please see the answer to your previous post Another Master's answer Sample Size II Expected power answer Sample Size and regulators Sample Size and sponsors Sample Size and spongulators Sample Size and regulators Sample Size and regulators	BE-proff	2016-12-28 08:14	10	2016-12-29 11:39	10,426
Why do we need pooled CV? Maximum CV might be misleading Maximum CV might be misleading Pooling – example Pooling – example in my protocols… Why do we need pooled CV? Yessir! Common sense! Common sense weighting before pooling Gut feeling is the answer! The reasons not to pool The reasons not to pool Know your drug/formulation!	BE-proff	2016-08-24 08:48	12	2016-12-29 11:27	14,309