Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
ICH M13B: Step 2b (draft for consultation) ICH M13B: EMA	Helmut	2025-03-15 10:31	1	2025-04-09 09:10	3,138
EMA: GL on quality and equivalence of LALA cutaneous products	Helmut	2024-10-03 11:41	0		1,810
ICH M13A: Changes to Step 2 ICH M13A: Changes to Step 2 AUCres ‘Percentage covered’ ICH M13A: Changes to Step 2 fixed or mixed effects model fixed or mixed effects model fixed or mixed effects model fixed or mixed effects model fixed or mixed effects model ICH M13A: Changes to Step 2 period within group and formulation period within group and formulation ICH M13A: Step 4 → 5 Formal ICH Procedure ICH M13A: Changes to Step 2	Helmut	2024-07-31 13:16	15	2024-09-10 08:12	10,565
EMA: ICH M13A coming into effect 25 January 2025	Helmut	2024-09-04 11:30	0		2,385
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	4,449
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	4,233
Draft FDA guidance on data integrity in BA and BE studies	Ohlbe	2024-04-02 14:49	0		2,074
Handling and Retention of BA and BE Testing Samples	suchit_bhavsar	2024-03-27 04:09	0		2,329
Paper by the IPRP BEWGG	Ohlbe	2024-03-22 16:25	0		2,227
New EMA product specific guidance (PSG) New EMA product specific guidance (PSG)	SMA	2024-01-16 09:51	1	2024-01-17 10:12	3,771
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	9,142
WHO Draft on BCS-based Biowaivers	Helmut	2023-08-29 11:18	0		2,488
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	14,199
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	4,001
FDA draft guidance on transdermal systems	Ohlbe	2023-04-13 08:37	0		2,396