Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
BioBridges 2023 BioBridges 2023 - lectures available!	Conferences / Workshops	Helmut	2023-04-06 10:52	1	2023-10-31 16:33	6,161
Unusual / Distinct PK profile drug Unusual / Distinct PK profile drug	PK / PD	VijithRoy	2023-10-25 16:55	1	2023-10-26 15:36	3,341
Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) EMA: No AUC(0-72h) for all MR products	Regulatives / Guidelines	JP2030	2023-10-18 05:58	1	2023-10-18 07:09	3,248
open-label BE trials maintain blindness Blinded NCA Blinded NCA Blinded review of PK data: History… Blinded review of PK data: History… open-label BE trials maintain blindness open-label BE trials maintain blindness open-label BE trials maintain blindness open-label BE trials maintain blindness	Study Performance	kimhuang	2023-10-14 09:19	8	2023-10-18 00:50	4,841
Application and test region of vasoconstrictor assay Application and test region of vasoconstrictor assay	Regulatives / Guidelines	Kelen	2023-10-04 16:31	1	2023-10-17 09:34	3,192
Tmax 90% confidence interval Tmax 90% confidence interval link to the post of BEBAC golden collection link to the post of BEBAC golden collection CI for difference in Tmax Tmax problems	Regulatives / Guidelines	durga09	2023-09-08 10:21	5	2023-10-12 06:55	5,003
Carry over and statistical adjustment in BE computations Carry-over → 🚮 Carry-over → 🚮 Carry-over → 🚮 Carry-over Carry-over Carry-over Carry-over Carry-over more than 20% subject carry over effect investigation carry over effect investigation based on what? carry over effect investigation based on what? Outdated and wrong answers Wrong answer	General Statistics	Achievwin	2023-10-02 20:34	13	2023-10-06 13:20	5,994
Test License Test License Test License Remaining RLDs from pilot study Remaining RLDs from pilot study Remaining RLDs from pilot study- retention sample?	Regulatives / Guidelines	rajasekharkakarla	2018-10-06 08:05	5	2023-10-03 17:27	6,179
Pilot study data submission as pivotal study Pilot study data submission as pivotal study	Off Topic	qualityassurance	2023-10-02 12:06	1	2023-10-03 16:30	3,041
5th GBHI Conference Conference report Presentations Presentations	Conferences / Workshops	Helmut	2021-02-02 16:26	3	2023-09-26 14:11	7,286
ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) : FDA web site Knowledge is power… ICH M13A (IR BE): EMA consultation ICH M13A (IR BE): EMA comments received	BE/BA News	Helmut	2022-12-23 09:05	9	2023-09-18 10:54	7,914
Applied Course in Clinical Pharmacokinetics	Conferences / Workshops	Helmut	2023-09-14 15:28	0		2,272
FDA Workshop	Conferences / Workshops	Helmut	2023-09-11 12:53	0		2,258
WHO Draft on BCS-based Biowaivers	BE/BA News	Helmut	2023-08-29 11:18	0		2,125
homoscedasticity assumption in RSABE method heteroscedasticity in RSABE (and ABEL) heteroscedasticity in RSABE (and ABEL) homoscedasticity assumption in RSABE method Asking a pupil Asking a pupil	RSABE / ABEL	WinnieH	2023-08-18 08:57	5	2023-08-18 17:16	3,557