Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
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	3,840
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	4,042
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	2,898
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	5,177
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	3,186
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	3,846
FDA workshop on GLP and BA/BE inspections Agenda	Conferences / Workshops	Ohlbe	2024-04-23 16:39	1	2024-05-03 15:34	3,500
Orlistat PD Endpoint BE study	Regulatives / Guidelines	NK	2024-04-30 04:33	0		1,744
Ferrograd Folic 325 mg / 0.35 mg prolonged-release tablet Study Requirement / Analyte to measure	Design Issues	JP2030	2024-04-29 07:18	0		2,010
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	3,718
BioBridges 2024	Conferences / Workshops	Helmut	2024-04-23 13:56	0		12,397
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	3,548
Sponsor-CRO relationship Sponsor-CRO relationship	GxP / QC / QA	MDBKV	2024-04-17 05:38	1	2024-04-17 21:34	2,712
Parallel Group Adaptive Designs Strong Type I Error control + CI: Not yet… Strong Type I Error control + CI: Not yet… Strong Type I Error control + CI: Not yet… Strong Type I Error control + CI: Not yet… Parallel design: Only simulation-based methods so far Parallel design: Only simulation-based methods so far Parallel Group Adaptive Designs Simulations highly recommended Simulations highly recommended Simulations mandatory Simulations mandatory Reviews are confidential Reviews are confidential Not accepted and for a reason… Quod licet Iovi Non licet bovi Non licet bovi Quod licet bove?	Two-Stage / GS Designs	Alex	2023-12-22 10:08	18	2024-04-15 21:46	9,104
The order function The order function The order function The order function The order function The sort function The sort function lag-times of profiles and cor() Roaster VII/VIII, Bandana Castor, and Effiou Nomen est omen Nomen est omen Nomen est omen Nomen est omen Nomen est omen Nomen est omen Nomen est omen Source Source Inquiry Inquiry	🇷 for BE/BA	ElMaestro	2024-03-24 17:07	19	2024-04-15 09:54	7,838