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Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Multi-group studies ad nauseam Speed kills	Relaxation	2022-12-02 15:53	23	2023-02-25 16:18	3,302
ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) : FDA web site Knowledge is power… ICH M13A (IR BE): EMA consultation	Helmut	2022-12-23 09:05	8	2023-02-09 12:34	1,645
EMA Methodology Working Party EMA Methodology Working Party	Helmut	2022-10-01 09:53	1	2022-11-08 10:09	1,330
ANVISA RDC Nº 742 ANVISA RDC Nº 749	Helmut	2022-09-12 10:27	1	2022-09-16 17:13	1,479
ICH M12 (DDI studies)	Helmut	2022-07-29 13:53	0		878
EMA: New product-specific guidances How would you implement it? Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Range Range Range Range So many questions, so few answers Preliminary simulations Preliminary simulations Preliminary simulations Simulated distributions	Helmut	2022-04-08 15:17	14	2022-07-28 12:43	3,085
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology	suchit_bhavsar	2022-06-29 07:37	0		644
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	1,253
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	1,600
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	997
Observational studies Observational studies … real-world evidence …	Helmut	2021-12-27 10:24	2	2022-02-11 09:38	1,719
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	36,425
English translation of Japanese guidelines	Ohlbe	2021-10-26 11:48	0		942
GCC guidelines v3.0	Helmut	2021-10-25 20:03	0		1,013
4th GBHI report	Helmut	2021-09-29 18:03	0		1,070