Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Outlier in fully replicate BE study Outlier in fully replicate BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study - cherry-picking? Widening for clopidogrel BE study Hypotheses Hypotheses ABEL ≠ RSABE ABEL ≠ RSABE power.TOST.sim and uncertainty power.TOST.sim and uncertainty power.TOST.sim and uncertainty Distribution of PEs Distribution of PEs power.TOST.sim code power.TOST.sim code	Loky do	2021-06-16 00:49	17	2023-11-02 11:22	4,530
Outlier in fixed dose combination Outlier in fixed dose combination	yoyo87	2022-07-21 12:01	1	2022-07-21 16:55	1,232
Outlier for different regulatories Outlier for different regulatories	gsrao2022	2021-08-07 06:40	1	2021-08-07 09:27	2,185
Exclusion of Outlier Data Exclusion of Outlier Data Health Canada: read the guidance	surajpatel	2021-05-27 08:14	2	2021-05-27 08:14	1,996
diarrhea in Extended release study diarrhea in Extended release study diarrhea in Extended release study	Researcher101	2020-09-23 21:53	2	2020-09-24 11:18	1,595
Outlier Test using R-Software and Phoenix WinNonlin software in the BE Outlier Test using R-Software and Phoenix WinNonlin software in the BE Studentized & standardized residuals Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test bear for outlier detection analysis?	udayk	2020-03-06 09:00	6	2020-03-20 13:45	6,572
Outlier Tests Outlier Tests Outlier Tests Outlier Tests Outlier Tests Outlier Tests	GM	2018-07-30 13:57	5	2019-02-15 03:58	5,193
AUC <5% of TEST geometric mean AUC AUC <5% of TEST geometric mean AUC AUC <5% of TEST geometric mean AUC AUC <5% of TEST geometric mean AUC	vezz	2019-02-13 08:35	3	2019-02-13 11:09	3,776
Rules acc. to Health Canada Rules acc. to Health Canada Rules acc. to Health Canada Rules acc. to Health Canada Rules acc. to Health Canada Rules acc. to Health Canada for either the test or reference product? Discordant outliers Rules acc. to Health Canada Rules acc. to Health Canada ESD? ESD? Rules acc. to Health Canada Great post!	Helmut	2019-02-05 15:04	13	2019-02-07 09:37	8,195
Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion	Mohamed Yehia	2018-10-02 21:25	11	2018-10-03 21:47	7,437
Outliers in Replicated Crossover Study Which agency? Which agency? Residuals and Critical value Calculation? Outliers in Replicated Crossover Study Outliers in Replicated Crossover Study Outliers in Replicated Crossover Study I would stop Outliers in Replicated Crossover Study Sample size for the FDA NTID BE decision	pash413	2016-07-11 09:04	9	2017-10-05 15:25	30,203
Multiple Outliers using Lund’s Procedure Repetitive testing? Repetitive testing?	Pankaj Bhangale	2014-07-10 14:23	2	2014-07-11 11:30	6,289
FDA: Mini-study (retesting) FDA: Mini-study (retesting)	Helmut	2014-05-26 17:50	1	2014-05-27 19:52	4,347
Outlier in a BE study Outlier in a BE study Outlier in a BE study Outliers: reasons to not analyse? I wouldn’t do that Outlier in a BE study Outlier in a BE study Outlier in a BE study Outlier in a BE study	auditor	2013-11-14 10:38	8	2014-02-06 01:35	11,084
Replicate Study designs Replicate Study designs Replicate Study designs Replicate Study designs Replicate Study designs Re-testing Replicate Study designs	balakotu	2014-01-08 08:14	7	2014-01-08 15:16	14,804