Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Issue with PBE Calculation when Stage = 1 Issue with PBE Calculation when Stage = 1 Issue with PBE Calculation when Stage = 1	Regulatives / Guidelines	weiguo2122	2025-01-13 20:19	2	2025-01-15 20:45	2,467
ANVISA Guidelines on Participant Involvement in Clinical Trials ANVISA Guidelines on Participant Involvement in Clinical Trials	Regulatives / Guidelines	Rajul9	2024-11-24 18:19	1	2025-01-13 13:13	2,798
Interim Safety Analysis or Re-Screening Interim Safety Analysis or Re-Screening	Design Issues	professionalr	2025-01-09 22:56	1	2025-01-10 00:01	2,216
Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE]	Regulatives / Guidelines	jdfr	2024-12-05 16:34	12	2025-01-09 14:46	8,678
Do regulatory agencies accept steady-state equivalence studies? HVD(P)s: steady state = history HVD(P)s: steady state = history HVD(P)s: steady state = history Do regulatory agencies accept steady-state equivalence studies? steady-state in patients steady-state in patients	Design Issues	libaiyi	2024-12-04 08:34	6	2025-01-09 10:59	5,547
Clinical strategy for generic of biosimilar	Regulatives / Guidelines	qualityassurance	2025-01-09 08:41	0		1,641
Group-by-Treatment Interaction: the final word? Group-by-Treatment Interaction: FDA Group-by-Treatment Interaction: Rejoinder Group-by-Treatment Interaction: the final word? ANOVA of Model 1 ANOVA of Model 1 ANOVA of Model 1 Between vs Within Between vs Within Treatment-by-Group in PROC MIXED and PROC GLM? Treatment-by-Group in PROC MIXED and PROC GLM? Treatment-by-Group in PROC MIXED and PROC GLM? Treatment-by-Group in PROC MIXED and PROC GLM?	General Statistics	Helmut	2024-04-19 01:26	12	2024-12-17 10:26	8,360
Outlier Test using R-Software and Phoenix WinNonlin software in the BE Outlier Test using R-Software and Phoenix WinNonlin software in the BE Studentized & standardized residuals Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test bear for outlier detection analysis? bear for outlier detection analysis?	Outliers	udayk	2020-03-06 09:00	7	2024-12-16 20:44	10,756
Recovery testing FDA: ICH M10 implemented in November 2022 FDA: ICH M10 implemented in November 2022	Bioanalytics	Rasha	2024-12-16 10:29	2	2024-12-16 13:15	2,767
Questions about "sequence effect" mentioned in a FDA PSG	General Statistics	Darborn	2024-12-10 11:04	0		1,801
Mixed effects model: ML or REML	General Statistics	Mahmoud	2024-12-05 11:20	0		1,549
3rd Bioequivalence Conference 26 Feb 2025 in Amsterdam	Conferences / Workshops	SMA	2024-11-28 11:33	0		3,450
ISR ISR ISR ISR ISR	Study Assessment	Loky do	2024-11-21 12:04	4	2024-11-27 14:27	3,015
First Point Cmax USFDA First Point Cmax (also ICH M13A) First Point Cmax (also ICH M13A) FDA M13A First Point Cmax (also ICH M13A)	Study Assessment	NK	2024-09-13 06:48	4	2024-11-27 13:50	3,923
Group-by-Treatment Interaction (another round)	Study Assessment	Helmut	2024-11-27 12:01	0		1,446