Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
SFDA BE GL v3.1 (also GCC?) SFDA BE GL v3.1 (also GCC?) SFDA BE GL v3.1 (GCC reference?) SFDA BE GL v3.1 (also GCC?) SFDA BE GL v3.1 (also GCC)	Regulatives / Guidelines	Helmut	2023-06-23 08:55	4	2023-07-04 19:46	3,784
Stabilization period Stabilization period Stabilization period	Design Issues	Vismayi	2023-06-26 19:55	2	2023-06-30 15:13	3,197
Sensitization test	Regulatives / Guidelines	Kelen	2023-06-30 13:13	0		2,001
EMA: New product-specific guidances How would you implement it? Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Range Range Range Range So many questions, so few answers Preliminary simulations Preliminary simulations Preliminary simulations Revisions of the PSGLs final Revisions of the PSGLs final EMA: No problems with many sampling time points… New simulations & some desultory thoughts SCNR. A heretic alternative. Simulated distributions	BE/BA News	Helmut	2022-04-08 15:17	19	2023-06-30 11:50	14,229
concentration-time profile with two peaks or more concentration-time profile with two peaks or more concentration-time profile with two peaks or more What does ‘max’ in Cmax mean? What does ‘max’ in Cmax mean? Which software? Which software? tmax ≠ Cmax 🙂 tmax ≠ Cmax 🙂 tmax ≠ Cmax 🙂	NCA / SHAM	Imph	2023-06-27 13:06	9	2023-06-27 18:25	5,313
Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap PhEq_bootstrap in R bootf2BCA v1.1 bootf2BCA v1.2: seed bootf2BCA v1.2: seed Which packages, working directory? Which packages, working directory? bootf2BCA v1.2: seed bootf2BCA v1.3 bootf2BCA v1.3 bootf2BCA v1.1 bootf2BCA v1.3.1 (current since 2022-06-25) bootf2BCA v1.3.1 (current since 2022-06-25) Install required packages first Validation of PhEq_bootstrap Validation of PhEq_bootstrap	Software	Helmut	2018-07-12 17:47	21	2023-06-27 11:47	25,341
Outlier Outlier Visual inspection of the fit!	Study Assessment	NK	2023-06-27 03:57	2	2023-06-27 09:56	3,488
bear installation problem bear 2.9.1 on 🇷 4.3.1 bear 2.9.1 on 🇷 4.3.1	🇷 for BE/BA	Imph	2023-06-20 12:25	2	2023-06-22 09:02	3,816
SD crossover study with no washout any examples SD crossover study with no washout any examples SD crossover study with no washout any examples	Design Issues	Achievwin	2023-06-19 16:37	2	2023-06-20 14:48	3,135
Calculation of PE and 90% CI No ‘R1’ and ‘R2’ in replicate designs No ‘R1’ and ‘R2’ in replicate designs Rose is a rose is a rose is a rose No ‘R1’ and ‘R2’ in replicate designs	General Statistics	Brus	2023-06-14 16:34	4	2023-06-19 19:42	4,536
Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies	Study Assessment	Venkata Chaitanya Reddi	2023-06-14 10:19	4	2023-06-16 08:48	3,635
Including duplicates of Low, medium and High QCs during analytical method validation Including duplicates of Low, medium and High QCs during analytical method validation	Regulatives / Guidelines	Ayman Rabayah	2023-06-15 07:14	1	2023-06-15 08:36	3,085
Method for replicate design Method for replicate design Method for replicate design Method for replicate design Method for replicate design	Nonparametrics	d_labes	2008-01-23 16:00	4	2023-06-14 10:43	12,210
within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present within subject standard deviation in fully replicate design if carry over effect is present	General Statistics	Ankit Parikh	2023-06-08 13:54	5	2023-06-14 10:37	5,113
Linagliptin/Metformin Hydrochloride film-coated tablets Linagliptin/Metformin Hydrochloride film-coated tablets Linagliptin/Metformin Hydrochloride film-coated tablets	Study Assessment	Venkata Chaitanya Reddi	2023-06-09 07:18	2	2023-06-09 12:01	3,191