Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Requesting data for a publication 📥 ♻️ 🚀 📌	Helmut	2023-02-23 10:46	0		13,942
Questions about "sequence effect" mentioned in a FDA PSG	Darborn	2024-12-10 11:04	0		1,807
Mixed effects model: ML or REML	Mahmoud	2024-12-05 11:20	0		1,555
Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies	jag009	2024-10-14 01:44	6	2024-10-18 12:03	3,880
Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs	BEQool	2024-06-27 12:25	8	2024-07-03 13:37	5,280
Group-by-Treatment Interaction: the final word? Group-by-Treatment Interaction: FDA Group-by-Treatment Interaction: Rejoinder Group-by-Treatment Interaction: the final word? ANOVA of Model 1 ANOVA of Model 1 ANOVA of Model 1 Between vs Within Between vs Within Treatment-by-Group in PROC MIXED and PROC GLM? Treatment-by-Group in PROC MIXED and PROC GLM? Treatment-by-Group in PROC MIXED and PROC GLM? Treatment-by-Group in PROC MIXED and PROC GLM?	Helmut	2024-04-19 01:26	12	2024-12-17 10:26	8,382
Subject effect justification Subject effect justification	Dafni_C	2024-01-17 10:00	1	2024-01-17 12:30	3,830
Carry over and statistical adjustment in BE computations Carry-over → 🚮 Carry-over → 🚮 Carry-over → 🚮 Carry-over Carry-over Carry-over Carry-over Carry-over more than 20% subject carry over effect investigation carry over effect investigation based on what? carry over effect investigation based on what? Outdated and wrong answers Wrong answer	Achievwin	2023-10-02 20:34	13	2023-10-06 13:20	8,092
Calculation of PE and 90% CI No ‘R1’ and ‘R2’ in replicate designs No ‘R1’ and ‘R2’ in replicate designs Rose is a rose is a rose is a rose No ‘R1’ and ‘R2’ in replicate designs	Brus	2023-06-14 16:34	4	2023-06-19 19:42	4,522
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	5,094
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	4,469
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	4,887
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	6,174
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	5,563
How to calculate Within-subject variability in a replicated BE Models, models!	Brus	2022-12-25 09:21	1	2022-12-25 12:17	4,533