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	3,241
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	5,739
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	3,307
Data analysis and sample size for replicate study designs as per recent FDA guidance	Regulatives / Guidelines	balakotu	2023-05-23 12:16	0		1,998
regulatory guideline	Regulatives / Guidelines	wock	2023-05-22 06:06	0		2,061
Sexy… Apotex vs MSN	Off Topic	Helmut	2023-05-19 20:32	1	2023-05-20 20:38	3,093
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	5,556
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	3,187
R Validation R Validation R Validation R Validation	Power / Sample Size	Imph	2023-05-14 13:48	3	2023-05-15 13:42	3,191
Gender Effect on Clarithromycin	Regulatives / Guidelines	Neera	2023-05-15 09:24	0		1,984
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	7,823
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	3,394
Chile regulatory	Regulatives / Guidelines	Pharma_88	2023-05-10 04:19	0		1,859
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	29,342
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	3,930