Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Handling and Retention of BA and BE Testing Samples Handling and Retention of BA and BE Testing Samples	dshah	2024-03-26 17:15	1	2024-04-23 16:16	599
EMA: Draft GL for OIPs EMA: Draft GL for OIPs EMA: Draft GL for OIPs	Helmut	2024-04-19 15:40	2	2024-04-22 14:07	246
Draft FDA guidance on data integrity in BA and BE studies	Ohlbe	2024-04-02 14:49	0		394
Handling and Retention of BA and BE Testing Samples	suchit_bhavsar	2024-03-27 04:09	0		432
Paper by the IPRP BEWGG	Ohlbe	2024-03-22 16:25	0		417
New EMA product specific guidance (PSG) New EMA product specific guidance (PSG)	SMA	2024-01-16 09:51	1	2024-01-17 10:12	1,013
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	4,345
WHO Draft on BCS-based Biowaivers	Helmut	2023-08-29 11:18	0		1,118
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	6,242
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	1,424
FDA draft guidance on transdermal systems	Ohlbe	2023-04-13 08:37	0		1,088
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Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Multi-group studies ad nauseam Webinar: Recording available Speed kills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	6,568
EMA Methodology Working Party EMA Methodology Working Party	Helmut	2022-10-01 09:53	1	2022-11-08 10:09	2,460
ANVISA RDC Nº 742 ANVISA RDC Nº 749	Helmut	2022-09-12 10:27	1	2022-09-16 17:13	3,381
ICH M12 (DDI studies)	Helmut	2022-07-29 13:53	0		1,589