Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
"Dose or Strength to be Studied" in ICH M13A "Dose or Strength to be Studied" in ICH M13A "Dose or Strength to be Studied" in ICH M13A	Regulatives / Guidelines	Darborn	2024-09-30 01:14	2	2024-10-08 00:58	2,696
Draft guideline on quality and equivalence of topical products – still stuck? Patience… MWP Final & published	Regulatives / Guidelines	mittyri	2024-09-14 20:24	3	2024-10-03 11:44	2,984
EMA: GL on quality and equivalence of LALA cutaneous products	BE/BA News	Helmut	2024-10-03 11:41	0		1,814
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	2,450
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	2,371
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	10,573
error JFSR package scales ≥1.3.0	🇷 for BE/BA	jforbital	2024-09-09 03:18	1	2024-09-09 11:49	2,404
Pooling of studies? coverage probability M13 M13 Q&A	Regulatives / Guidelines	Helmut	2024-09-02 13:55	3	2024-09-06 08:31	3,571
risperidone AND water ODT vs IR risperidone AND water	Design Issues	Bebac user	2024-09-04 18:51	2	2024-09-06 06:15	2,722
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	4,539
EMA: ICH M13A coming into effect 25 January 2025	BE/BA News	Helmut	2024-09-04 11:30	0		2,388
Simulation-based 2×2×2 TSDs – a deep dive	Two-Stage / GS Designs	Helmut	2024-09-03 13:18	0		1,637
Cholestyramine and colesevelam in Vitro binding studies	Regulatives / Guidelines	jansari	2024-09-02 17:25	0		1,392
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	2,607
A rant A rant Parallel (replicate?)	Two-Stage / GS Designs	Helmut	2024-08-26 12:52	2	2024-08-28 10:54	2,670