Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
WHO Draft on BCS-based Biowaivers	Helmut	2023-08-29 11:18	0		250
ICH E6(R3) draft Guideline reaches Step 2 of the ICH process Validation of sample size estimations?	SMA	2023-05-24 08:37	1	2023-05-29 08:34	752
FDA draft guidance on transdermal systems	Ohlbe	2023-04-13 08:37	0		633
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 ICH M13A (IR BE): EMA comments received	Helmut	2022-12-23 09:05	9	2023-09-18 10:54	2,631
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Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Multi-group studies ad nauseam Webinar: Recording available Speed kills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	4,918
EMA Methodology Working Party EMA Methodology Working Party	Helmut	2022-10-01 09:53	1	2022-11-08 10:09	1,757
ANVISA RDC Nº 742 ANVISA RDC Nº 749	Helmut	2022-09-12 10:27	1	2022-09-16 17:13	2,233
ICH M12 (DDI studies)	Helmut	2022-07-29 13:53	0		1,119
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology	suchit_bhavsar	2022-06-29 07:37	0		847
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	1,756
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	1,978
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 Revisions of the PSGLs final Revisions of the PSGLs final EMA: No problems with many sampling time points… New simulations & some desultory thoughts SCNR. A heretic alternative. Simulated distributions	Helmut	2022-04-08 15:17	19	2023-06-30 11:50	4,617
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	1,340
Observational studies Observational studies … real-world evidence …	Helmut	2021-12-27 10:24	2	2022-02-11 09:38	2,013
English translation of Japanese guidelines	Ohlbe	2021-10-26 11:48	0		1,136