Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Ebastine study design Ebastine study design	Design Issues	Bebac user	2023-11-25 13:07	1	2023-11-27 09:53	3,553
ChatGPT generates fake data set to support scientific hypothesis ChatGPT generates fake data set to support legal case	Off Topic	Helmut	2023-11-24 08:10	1	2023-11-24 15:57	3,615
Outlier in fully replicate BE study Outlier in fully replicate BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study - cherry-picking? Widening for clopidogrel BE study Hypotheses Hypotheses ABEL ≠ RSABE ABEL ≠ RSABE power.TOST.sim and uncertainty power.TOST.sim and uncertainty power.TOST.sim and uncertainty Distribution of PEs Distribution of PEs power.TOST.sim code power.TOST.sim code	Outliers	Loky do	2021-06-16 00:49	17	2023-11-02 11:22	9,669
BioBridges 2023 BioBridges 2023 - lectures available!	Conferences / Workshops	Helmut	2023-04-06 10:52	1	2023-10-31 16:33	6,784
Unusual / Distinct PK profile drug Unusual / Distinct PK profile drug	PK / PD	VijithRoy	2023-10-25 16:55	1	2023-10-26 15:36	3,560
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	3,568
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	5,949
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	3,582
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	5,581
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 Outdated and wrong answers Wrong answer	General Statistics	Achievwin	2023-10-02 20:34	13	2023-10-06 13:20	8,115
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	6,556
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	3,597
5th GBHI Conference Conference report Presentations Presentations	Conferences / Workshops	Helmut	2021-02-02 16:26	3	2023-09-26 14:11	7,950
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	9,163
Applied Course in Clinical Pharmacokinetics	Conferences / Workshops	Helmut	2023-09-14 15:28	0		2,559