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	259
Unannounced inspections, FDA	ElMaestro	2023-12-19 08:54	0		711
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	3,592
WHO Letter of Concern	Ohlbe	2022-11-28 09:56	0		1,639
Open Position at WHO	Helmut	2022-11-03 14:19	0		1,455
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	6,754
ICH GCP type of the data ICH GCP type of the data	Beholder	2021-04-05 11:56	1	2021-04-05 19:35	1,945
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	2,626
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	2,494
Reference ranges, prediction intervals Reference ranges, prediction intervals Reference ranges, prediction intervals	ElMaestro	2020-06-20 22:41	2	2020-06-22 13:38	2,482
Stability of IPs Stability of IPs Stability of IPs	Loky do	2020-06-10 13:31	2	2020-06-16 11:24	2,606
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	3,842
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	3,864
Randomization access Randomization access	akash	2019-08-16 07:43	1	2019-08-16 11:28	2,802
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	6,754