Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Method Validation HQC concentration	Bioanalytics	Loky do	2025-03-13 11:19	1	2025-03-14 17:13	2,603
ICH M13A complex study designs missing data and data excluded ICH M13A: Two-at-a-Time ICH M13A: Two-at-a-Time ICH M13A: Descriptive statistics ICH M13A: Descriptive statistics	Regulatives / Guidelines	kimhuang	2025-03-04 08:12	4	2025-03-08 05:55	3,823
Bioequivalence study in Multiple countries Bioequivalence study in Multiple countries	Study Performance	Achievwin	2025-02-21 02:02	1	2025-03-07 19:02	2,653
BE study for Minoxidil FDA PSGs: Alternative approach BE study for Minoxidil BE study for Minoxidil BE study for Minoxidil	Design Issues	jag009	2025-02-20 06:24	4	2025-03-01 20:29	3,053
2-period full replicate design for IR formulation – EMA perspective 2-period full replicate design for IR formulation – EMA perspective	Regulatives / Guidelines	Ankit Parikh	2024-07-11 04:58	1	2025-03-01 12:33	2,990
Question about Williams Design	Design Issues	Bebac user	2025-02-25 20:30	0		1,459
Significance Significance Significance Quality vs. Clinical Sample size? Sample size? Sample size? Sample size, ratio, CV ↔ power Sample size, ratio, CV ↔ power Sample size, ratio, CV ↔ power TOST != treatment effect Sample size, ratio, CV ↔ power Not vice versa Not vice versa? Not vice versa? Sample size calculation using Marzo and Balant method Marzo / Balant formula Marzo / Balant formula Marzo / Balant formula Marzo / Balant formula for parallel groups	Power / Sample Size	The Outlaw Torn	2012-11-20 07:56	19	2025-02-25 06:12	17,616
different ranks/levels of William design? different ranks/levels of William design? "ranking" William designs "ranking" William designs "ranking" William designs	Design Issues	Shuanghe	2025-02-12 00:46	4	2025-02-23 11:47	2,678
Product Labelling Query Product Labelling Query	Regulatives / Guidelines	professionalr	2025-02-18 22:01	1	2025-02-18 23:38	2,104
how to construct confidence interval for un-transformed metric? how to construct confidence interval for un-transformed metric? how to construct confidence interval for un-transformed metric? Fieller’s confidence interval Fieller’s confidence interval Fieller’s confidence interval Rescue approaching – PowerTOST Rescue approaching – PowerTOST Why not base 🇷? Why not base 🇷?	Power / Sample Size	lizhao	2016-02-17 19:01	9	2025-02-15 20:42	13,251
Method A of EMA ABEL: Why Excel? ABEL: Why Excel?	Software	dshah	2025-02-10 07:27	2	2025-02-10 15:40	2,321
Bioequivalence studies for GCC submission Bioequivalence studies for GCC submission	Design Issues	professionalr	2025-01-30 23:00	1	2025-01-31 03:20	2,233
Conducting PK study in Mexico	Regulatives / Guidelines	jag009	2025-01-28 20:13	0		1,803
European Economic Area: ICH M13A effective with 25 January 2025	Regulatives / Guidelines	Helmut	2025-01-28 10:49	0		1,534
Stratified randomisation in parallel BE studies and ANOVA model Stratified randomisation in parallel BE studies	Design Issues	BEQool	2024-11-14 12:42	1	2025-01-27 08:03	2,397