Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Sponsor-CRO relationship Sponsor-CRO relationship	MDBKV	2024-04-17 05:38	1	2024-04-17 21:34	353
Unannounced inspections, FDA	ElMaestro	2023-12-19 08:54	0		725
Another one? Confirmed Who cares? Who cares? Expert Questions about data manipulation Data manipulation Questions about data manipulation Update Another one?	Helmut	2023-07-19 09:04	9	2024-03-22 20:29	3,701
WHO Letter of Concern	Ohlbe	2022-11-28 09:56	0		1,643
Open Position at WHO	Helmut	2022-11-03 14:19	0		1,459
Another two... Another two... Dates Some more info EU Article 31 referral started Cheating Increased variability Increased variability Visualization Another two... Another two... Blind monitors or greedy sponsors? Blind monitors or greedy sponsors? Blind monitors or greedy sponsors? Blind monitors or greedy sponsors? (Cumulative) T/R-ratio vs. time Sponsors and CRO selection I still think that T/R-ratios are useful T/R-ratios are useful T/R-ratios are useful Bust the Buster complicate the assessor's life complicate the assessor's life complicate the assessor's life Thanks for Busting the Buster Thanks for Busting the Buster A small point for the code A small point for the code	Ohlbe	2021-09-16 23:41	27	2022-06-01 12:11	6,797
ICH GCP type of the data ICH GCP type of the data	Beholder	2021-04-05 11:56	1	2021-04-05 19:35	1,961
Auditor NDA/CDA Auditor NDA/CDA Auditor NDA/CDA Auditor NDA/CDA Auditor NDA/CDA	ElMaestro	2021-03-09 18:22	4	2021-03-16 05:29	2,634
BE Study- Remote Monitoring - EMEA study EMA: Clinical Trials during COVID-19 pandemic EMA: Clinical Trials during COVID-19 pandemic	biopk	2020-06-22 07:03	2	2020-06-23 06:15	2,503
Reference ranges, prediction intervals Reference ranges, prediction intervals Reference ranges, prediction intervals	ElMaestro	2020-06-20 22:41	2	2020-06-22 13:38	2,495
Stability of IPs Stability of IPs Stability of IPs	Loky do	2020-06-10 13:31	2	2020-06-16 11:24	2,612
New Art. 31 referral: suspected data manipulation again New Art. 31 referral: suspected data manipulation again Referral concluded 💯	Ohlbe	2020-02-28 14:23	3	2020-07-24 16:00	3,852
Reporting of QA Reporting of QA Reporting of QA Reporting of QA	kishan_123	2019-11-06 15:27	3	2019-11-11 08:14	3,875
Randomization access Randomization access	akash	2019-08-16 07:43	1	2019-08-16 11:28	2,808
Impartial Witness in BABE study Impartial Witness in BABE study Impartial Witness in BABE study New Drugs and Clinical Trials Rules: Wrong definition of BE Husband ≠ impartial Husband ≠ impartial Husband ≠ impartial Impartial Witness in BABE study	yatish gosai	2019-05-22 07:49	7	2019-05-24 10:20	6,774