Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Switchability with replicate design studies Switchability = IBE Switchability = IBE S × F interaction S × F interaction S × F interaction S × F interaction S × F interaction	Design Issues	Achievwin	2022-05-20 04:44	7	2023-06-08 10:21	4,800
Reference-Scaled Average Bioequivalence FDA: TRT\|RTR instead of TRR\|RTR\|RRT?	RSABE / ABEL	Brus	2023-06-06 12:18	1	2023-06-07 10:22	3,111
Sample size estimation for parallel design with more than 2 treatments Sample size estimation for parallel design with more than 2 treatments >2 treatments, multiplicity or not >2 treatments, multiplicity or not	Power / Sample Size	BEQool	2023-05-24 21:05	3	2023-05-29 10:41	4,093
ICH E6(R3) draft Guideline reaches Step 2 of the ICH process Validation of sample size estimations?	BE/BA News	SMA	2023-05-24 08:37	1	2023-05-29 08:34	4,012
Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ If you have data… If you have data… Washout based on mean ± SD of t½ Washout based on mean ± SD of t½ Washout based on mean ± SD of t½	Design Issues	Imph	2022-09-25 13:52	9	2023-05-27 08:36	6,205
Sample Size Benefits of Replicate Design with ABE Sample Size Benefits of Replicate Design with ABE Dropouts less problematic	Power / Sample Size	Sereng	2023-05-24 15:41	2	2023-05-25 16:27	3,857
Data analysis and sample size for replicate study designs as per recent FDA guidance	Regulatives / Guidelines	balakotu	2023-05-23 12:16	0		2,164
regulatory guideline	Regulatives / Guidelines	wock	2023-05-22 06:06	0		2,189
Sexy… Apotex vs MSN	Off Topic	Helmut	2023-05-19 20:32	1	2023-05-20 20:38	3,660
FDA’s mixed model for ABE: another round emmeans for lme when the data is incomplete	🇷 for BE/BA	Helmut	2019-08-19 13:07	1	2023-05-20 20:19	6,151
Design for the EMA BE for the EMA BE for the EMA BE for the EMA	Regulatives / Guidelines	ryraman2661	2023-05-15 13:03	3	2023-05-16 08:51	3,462
R Validation R Validation R Validation R Validation	Power / Sample Size	Imph	2023-05-14 13:48	3	2023-05-15 13:42	3,791
Gender Effect on Clarithromycin	Regulatives / Guidelines	Neera	2023-05-15 09:24	0		2,137
Inclusion criteria in BE studies BE: ♀♂ Inclusion criteria in BE studies Stratify for sex? Stratify for sex? Inclusion criteria in BE studies Inclusion criteria in BE studies Inclusion criteria in BE studies Sex-by-treatment interaction Sex-by-treatment interaction	Design Issues	Loky do	2020-05-22 18:16	9	2023-05-11 09:12	8,454
505 b(2) application & requirement of bioequivalence 505 b(2) application & requirement of bioequivalence 505 b(2) application & requirement of bioequivalence 505 b(2) application & requirement of bioequivalence 505 b(2) application & requirement of bioequivalence	Regulatives / Guidelines	Mithu	2023-05-04 04:59	4	2023-05-11 07:58	3,747