Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
ICH M13 Guidance and Health Canada ICH M13A/C and Health Canada	Regulatives / Guidelines	AB661	2024-10-01 05:09	1	2024-10-01 06:29	1,695
software for calculating sample size for replicate bioequivalence studies 🇷 package PowerTOST	Power / Sample Size	gsrao2022	2024-09-24 17:21	1	2024-09-24 19:33	1,739
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	BE/BA News	Helmut	2024-07-31 13:16	15	2024-09-10 08:12	7,426
error JFSR package scales ≥1.3.0	🇷 for BE/BA	jforbital	2024-09-09 03:18	1	2024-09-09 11:49	1,671
Pooling of studies? coverage probability M13 M13 Q&A	Regulatives / Guidelines	Helmut	2024-09-02 13:55	3	2024-09-06 08:31	2,628
risperidone AND water ODT vs IR risperidone AND water	Design Issues	Bebac user	2024-09-04 18:51	2	2024-09-06 06:15	1,995
Problem with bear 2.9.1 Problem with bear 2.9.1 Problem with bear 2.9.1 Did you try? Did you try? Perseverance… Perseverance… Getting tired 😴	🇷 for BE/BA	Balu	2024-08-30 05:42	7	2024-09-04 14:12	3,015
EMA: ICH M13A coming into effect 25 January 2025	BE/BA News	Helmut	2024-09-04 11:30	0		1,705
Simulation-based 2×2×2 TSDs – a deep dive	Two-Stage / GS Designs	Helmut	2024-09-03 13:18	0		1,122
Cholestyramine and colesevelam in Vitro binding studies	Regulatives / Guidelines	jansari	2024-09-02 17:25	0		1,018
Compound highly variable Always full (!) replicate pilot for reference-scaling Always full (!) replicate pilot for reference-scaling	Design Issues	Laura Carreiras	2024-08-28 08:20	2	2024-09-02 13:52	1,918
A rant A rant Parallel (replicate?)	Two-Stage / GS Designs	Helmut	2024-08-26 12:52	2	2024-08-28 10:54	2,234
A dumb question A dumb answer A dumb answer A dumb answer A dumb answer A dumb answer An alternate dumb answer An alternate dumb answer Unconjugated ≠ free Unconjugated ≠ free A dumb question	Bioanalytics	jag009	2024-08-12 13:17	10	2024-08-27 03:02	3,195
Leuprolide 1 month product shelf life	Design Issues	Achievwin	2024-08-27 02:47	0		1,175
Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs	Regulatives / Guidelines	Achievwin	2024-08-05 18:50	2	2024-08-27 02:42	2,118