Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Biocomparability study Biocomparability study	Regulatives / Guidelines	suchit_bhavsar	2024-06-12 09:01	1	2024-06-12 09:48	2,508
Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission All samples might be informative Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission	Bioanalytics	shreyas goswami	2024-06-01 11:13	6	2024-06-06 20:26	4,472
Time Scaling In Vitro vs In Vivo	Dissolution / BCS / IVIVC	rezkighassani	2024-06-03 06:23	0		1,954
CV% and confidence interval Phoenix WinNonlin vs PowerTOST Phoenix WinNonlin vs PowerTOST Phoenix WinNonlin: Variance estimate → CV, Welch-test Base 🇷 for comparison Base 🇷 for comparison	Software	Darborn	2024-05-29 08:26	5	2024-05-31 02:07	4,796
Single dose PK study on Patients Single dose PK study on Patients Single dose PK study on Patients No, sorry No, sorry Deviating from a guidance Deviating from a guidance No, sorry	Design Issues	Pharma_88	2024-05-15 05:37	7	2024-05-21 12:41	4,835
PKNCA calculation of AUC PKNCA defaults to the linear-up/log-down rule	🇷 for BE/BA	jag009	2024-05-19 23:45	1	2024-05-20 07:39	3,520
Large sample size in a BE study My record: ≈400 My record: ≈400 My record: ≈400 My record: ≈400 n=180 4-period full replicate n=180 4-period full replicate HVNTID! n=180 4-period full replicate Lousy T/R-ratio n=180 4-period full replicate	Design Issues	Achievwin	2024-05-03 13:28	10	2024-05-17 13:45	6,201
A Short History of Bioequivalence A Short History of Bioequivalence A Short History of Bioequivalence	Off Topic	Helmut	2024-05-05 13:33	2	2024-05-08 22:50	3,851
Probability of Success in BE studies Probability of Success in BE studies Probability of Success in BE studies Probability of Success in BE studies Probability of Success in BE studies Assumptions (plural) Assumptions (plural)	Design Issues	Achievwin	2024-05-03 13:43	6	2024-05-06 15:51	4,575
FDA workshop on GLP and BA/BE inspections Agenda	Conferences / Workshops	Ohlbe	2024-04-23 16:39	1	2024-05-03 15:34	3,997
Orlistat PD Endpoint BE study	Regulatives / Guidelines	NK	2024-04-30 04:33	0		1,963
Ferrograd Folic 325 mg / 0.35 mg prolonged-release tablet Study Requirement / Analyte to measure	Design Issues	JP2030	2024-04-29 07:18	0		2,281
Handling and Retention of BA and BE Testing Samples Handling and Retention of BA and BE Testing Samples	BE/BA News	dshah	2024-03-26 17:15	1	2024-04-23 16:16	4,451
BioBridges 2024	Conferences / Workshops	Helmut	2024-04-23 13:56	0		12,712
EMA: Draft GL for OIPs EMA: Draft GL for OIPs EMA: Draft GL for OIPs	BE/BA News	Helmut	2024-04-19 15:40	2	2024-04-22 14:07	4,237