Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Ooops ! They did it again Ooops²	Ohlbe	2025-03-28 19:22	1	2025-03-30 11:57	626
Case Report Form (CRF) as source data Case Report Form (CRF) as source data Case Report Form (CRF) as source data Case Report Form (CRF) as source data Case Report Form (CRF) as source data	Mais	2024-06-24 07:04	4	2024-06-26 06:23	2,705
Another one? Confirmed Who cares? Who cares? Expert Questions about data manipulation Data manipulation Questions about data manipulation Questions about data manipulation Questions about data manipulation Questions about data manipulation Questions about data manipulation Assessment report published Questions about data manipulation Questions about data manipulation OT Questions about data manipulation Update Health Canada recalls And the FDA… Another one?	Helmut	2023-07-19 09:04	20	2024-06-19 11:22	12,104
Sponsor-CRO relationship Sponsor-CRO relationship	MDBKV	2024-04-17 05:38	1	2024-04-17 21:34	2,621
Unannounced inspections, FDA	ElMaestro	2023-12-19 08:54	0		1,804
WHO Letter of Concern	Ohlbe	2022-11-28 09:56	0		2,402
Open Position at WHO	Helmut	2022-11-03 14:19	0		2,251
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	11,766
ICH GCP type of the data ICH GCP type of the data	Beholder	2021-04-05 11:56	1	2021-04-05 19:35	3,102
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	4,102
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	5,204
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	3,620
Reference ranges, prediction intervals Reference ranges, prediction intervals Reference ranges, prediction intervals	ElMaestro	2020-06-20 22:41	2	2020-06-22 13:38	3,862
Stability of IPs Stability of IPs Stability of IPs	Loky do	2020-06-10 13:31	2	2020-06-16 11:24	3,734
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	5,059