Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present	Ankit Parikh	2023-06-08 13:54	5	2023-06-14 10:37	7,580
average bioequivalence: MLE vs. REML average bioequivalence: MLE vs. REML average bioequivalence: MLE vs. REML average bioequivalence: MLE vs. REML	Mahmoud	2023-03-11 12:21	3	2023-03-16 23:51	6,853
Variance VS Coefficient of variation s² ↔ CV CV ≈ s for low variances CV ≈ s for low variances CV ≈ s for low variances	Imph	2023-02-27 09:09	4	2023-03-06 12:42	7,313
Are Statistical Analysis Plans “required” for Pivotal Studies? SAP vs. part of the clinical protocol SAP vs. part of the clinical protocol Traceability Are Statistical Analysis Plans “required” for Pivotal Studies? Are Statistical Analysis Plans “required” for Pivotal Studies?	Sereng	2023-02-08 18:23	5	2023-02-16 06:55	8,335
Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind Blinded NCA in Phoenix/WinNonlin Blinded NCA in Phoenix/WinNonlin Blinded NCA in Phoenix/WinNonlin Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind Phoenix: Locked Workflows Phoenix: Locked Workflows Blind forever? Blind forever?	Imph	2023-02-12 08:31	8	2023-02-15 11:00	9,723
How to calculate Within-subject variability in a replicated BE Models, models!	Brus	2022-12-25 09:21	1	2022-12-25 12:17	6,585
Confidence intervals Confidence intervals	Bebac user	2022-12-19 13:59	1	2022-12-21 21:11	5,854
Observations in a linear model Observations in a linear model Observations in a linear model Observations in a linear model And the Oscar goes to: Replicates! It's all in the df's	Helmut	2022-11-15 10:55	5	2022-11-18 17:28	7,804
Parameter affecting Subject by formulation	Mithu	2022-06-07 09:12	0		3,180
Defining time to concentration threshold Defining time to concentration threshold I prefer interpolation I prefer interpolation Continuous variable → mean	Cytokrom C	2022-04-29 16:24	4	2022-05-01 22:05	6,707
IWRES and NPDE vs time/concentration plots interpretation IWRES and NPDE vs time/concentration plots interpretation	jmt3	2022-04-03 08:25	1	2022-04-05 07:56	5,506
Adjusting weight to reflect group differences in Model Adjusting weight to reflect group differences in Model Adjusting weight to reflect group differences in Model Adjusting weight to reflect group differences in Model	balakotu	2022-03-29 11:24	3	2022-03-30 09:19	6,316
Normal distribution assessment Normal distribution assessment Normal distribution assessment Testing ‘randomness’ Normal distribution assessment	BE-proff	2022-02-20 19:07	4	2022-02-27 17:49	6,532
statistical analysis of William's Design ’Two at a Time’ approach ’Two at a Time’ approach	Ahikal	2021-12-13 17:41	2	2021-12-13 17:06	6,003
Achievement of Steady State Achievement of Steady State: Visual inspection & common sense Achievement of Steady State: Visual inspection & common sense Threshold of % change? Threshold of % change? Keep it simple	arl_stat	2021-07-31 07:42	5	2021-10-20 10:36	9,583