Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
New guidance on Statistical Approaches to Establishing Bioequivalence A first look A first look A first look SAS strikes back SAS strikes back Outliers? Outliers? SAS strikes back model-based BE? model-based BE? Hooker, Moellenhoff et al. are moving MBBE forward model-based BE? A first look A first look Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Multi-group studies ad nauseam Webinar: Recording available Speed kills	Relaxation	2022-12-02 15:53	24	2023-04-01 10:38	14,827
EMA Methodology Working Party EMA Methodology Working Party	Helmut	2022-10-01 09:53	1	2022-11-08 10:09	4,615
ANVISA RDC Nº 742 ANVISA RDC Nº 749	Helmut	2022-09-12 10:27	1	2022-09-16 17:13	6,921
ICH M12 (DDI studies)	Helmut	2022-07-29 13:53	0		2,838
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology	suchit_bhavsar	2022-06-29 07:37	0		2,427
Publication of the final ICH M10 guideline Publication of the final ICH M10 guideline Chromatograms	Ohlbe	2022-06-10 10:48	2	2022-06-14 09:37	4,732
New FDA bioavailability guidance New FDA bioavailability guidance New FDA bioavailability guidance Excellent post!	wienui	2022-04-15 09:44	3	2022-04-17 11:03	5,087
Bempedoic Acid TBM BE study in SBOA Bempedoic Acid TBM BE study in SBOA	dshah	2022-03-30 17:09	1	2022-03-31 06:43	4,192
Observational studies Observational studies … real-world evidence …	Helmut	2021-12-27 10:24	2	2022-02-11 09:38	4,674
EMA BE-GL: Clarifications / Corrections? Good news!? Good news!? Update Q&A published 14 March 2011 Q&A published 14 March 2011 Phoenix/WinNonlin 6.1.0.173 ANOVA party prevails THX! Outlier Outliers - yes, but how? Questions and Ambiguities Residuals and Outliers in Replicate Design Crossover Studies Info requested Confused as well... Q&A published 14 March 2011 SAS code: Warning Copy & paste Subtleties, flaws, questions Subtleties, flaws, questions Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Food not the same between groups Food not the same between groups	Helmut	2010-06-22 18:53	26	2021-11-17 08:50	47,165
English translation of Japanese guidelines	Ohlbe	2021-10-26 11:48	0		2,513
GCC guidelines v3.0	Helmut	2021-10-25 20:03	0		2,633
4th GBHI report	Helmut	2021-09-29 18:03	0		2,787
FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021 Bias correction unveiled FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021	ElMaestro	2021-08-23 14:42	5	2021-09-10 18:47	6,283
WHO: scaling for AUC? WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: scaling for AUC confirmed No comparison of variabilities any more? WHO: scaling for AUC confirmed EMA: scaling for AUC = utopia	Ohlbe	2017-06-12 13:29	9	2021-08-03 10:54	15,244