Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	3,415
Unannounced inspections, FDA	ElMaestro	2023-12-19 08:54	0		692
WHO Letter of Concern	Ohlbe	2022-11-28 09:56	0		1,623
Open Position at WHO	Helmut	2022-11-03 14:19	0		1,441
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	6,690
ICH GCP type of the data ICH GCP type of the data	Beholder	2021-04-05 11:56	1	2021-04-05 19:35	1,916
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	2,594
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	3,808
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	2,461
Reference ranges, prediction intervals Reference ranges, prediction intervals Reference ranges, prediction intervals	ElMaestro	2020-06-20 22:41	2	2020-06-22 13:38	2,447
Stability of IPs Stability of IPs Stability of IPs	Loky do	2020-06-10 13:31	2	2020-06-16 11:24	2,565
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	3,827
Randomization access Randomization access	akash	2019-08-16 07:43	1	2019-08-16 11:28	2,767
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	6,697
Sample Shipment (dry ice) ☣ Sample Shipment (dry ice) ☣ Sample Shipment (dry ice) ☣ Satisfaction? Satisfaction?	Helmut	2019-04-10 15:03	4	2019-04-12 16:59	4,449