Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
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	3,246
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	5,755
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	3,312
Data analysis and sample size for replicate study designs as per recent FDA guidance	Regulatives / Guidelines	balakotu	2023-05-23 12:16	0		2,003
regulatory guideline	Regulatives / Guidelines	wock	2023-05-22 06:06	0		2,067
Sexy… Apotex vs MSN	Off Topic	Helmut	2023-05-19 20:32	1	2023-05-20 20:38	3,096
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	5,562
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	3,195
R Validation R Validation R Validation R Validation	Power / Sample Size	Imph	2023-05-14 13:48	3	2023-05-15 13:42	3,198
Gender Effect on Clarithromycin	Regulatives / Guidelines	Neera	2023-05-15 09:24	0		1,987
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	7,830
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	3,403
Chile regulatory	Regulatives / Guidelines	Pharma_88	2023-05-10 04:19	0		1,866
Sample size estimation for parallel design Parallel designs (total variance) Parallel designs (total variance) CV-intra # 60% CV-inter total (pooled) variance: examples total (pooled) variance: examples total (pooled) variance: examples Higher-Order Crossovers Higher-Order Crossovers total (pooled) variance: examples total (pooled) variance: examples total (pooled) variance: examples total (pooled) variance: examples total (pooled) variance: examples total (pooled) variance: examples Sample size estimation for parallel design	Power / Sample Size	Nav Coelho	2007-07-20 16:14	15	2023-05-04 08:17	29,359
ABE results from SAS and WinNolin are not matched ABE results from SAS and WinNolin are not matched Variable names, lexical order? Variable names, lexical order? Variable names, lexical order? Variable names, lexical order?	Regulatives / Guidelines	weiguo2122	2023-04-19 14:43	5	2023-04-21 15:45	3,936