Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
WHO Letter of Concern	Ohlbe	2022-11-28 09:56	0		761
Open Position at WHO	Helmut	2022-11-03 14:19	0		831
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	4,703
ICH GCP type of the data ICH GCP type of the data	Beholder	2021-04-05 11:56	1	2021-04-05 19:35	1,343
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	1,807
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	2,992
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	1,793
Reference ranges, prediction intervals Reference ranges, prediction intervals Reference ranges, prediction intervals	ElMaestro	2020-06-20 22:41	2	2020-06-22 13:38	1,828
Stability of IPs Stability of IPs Stability of IPs	Loky do	2020-06-10 13:31	2	2020-06-16 11:24	1,984
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	3,205
Randomization access Randomization access	akash	2019-08-16 07:43	1	2019-08-16 11:28	2,184
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	5,813
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	3,647
Training of SOPs Training of SOPs Training of SOPs Training of SOPs	Pandu	2019-03-25 11:16	3	2019-03-27 07:14	2,936
GLP or GCP for bioanalysis? GLP or GCP for bioanalysis? GLP or GCP for bioanalysis? Both, Cap't'n ! Both, Cap't'n ! Both, Cap't'n ! Both, Cap't'n ! Both, Cap't'n ! Both, Cap't'n ! A great idea Statements of GCP and GLP compliance	ElMaestro	2019-01-20 11:42	10	2019-01-22 23:29	6,443