Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
Sample Size Estimation in Bioequivalence 💯 📌 Evaluation ☑️	Surveys	Helmut	2020-05-20 22:39	1	2020-06-03 12:36	16,987
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		118,419
Parodic paper in predatory journal Parodic paper in predatory journal Parodic paper in predatory journal Parodic paper in predatory journal	Off Topic	Ohlbe	2020-09-15 15:09	3	2020-09-18 13:14	192
ICH M9 - reverse engineering? ICH M9 - reverse engineering? ICH M9 - reverse engineering?	Regulatives / Guidelines	MSimoes	2020-09-16 16:01	2	2020-09-17 15:56	130
Retention for multicenter patient BABE study Retention for multicenter patient BABE study	Regulatives / Guidelines	pash413	2020-09-06 17:43	1	2020-09-14 14:21	506
EMA: Waiving MD study EMA: Waiving MD study EMA: Waiving MD study PK model Zero order helps often Zero order helps often Distributed delay	Regulatives / Guidelines	Helmut	2020-09-09 16:21	6	2020-09-11 05:31	1,171
Design Jurisdiction? Jurisdiction? EMA: ABEL for HVD(P)s, PK metrics EMA: ABEL for HVD(P)s, PK metrics EMA: MD PK metrics	Regulatives / Guidelines	Pharma_88	2020-08-27 16:07	5	2020-09-08 17:25	1,379
normality, inter- & intra-subject analyses w/ replicates	R for BE/BA	jabriges	2020-09-01 23:06	0		479
EMA: Hybrid MR vs IR (inter-individual variability)	Power / Sample Size	Helmut	2020-09-01 13:57	0		564
Document Retention Period for Bioequivalence study Turkish Submission Website of the Turkish Medicines and Medical Devices Agency Document Retention Period for Bioequivalence study Turkish Submission Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? ICH = 2 Years after last approval based on study	Regulatives / Guidelines	yatish gosai	2020-08-10 14:36	5	2020-09-01 11:03	1,968
Assumptions in BE	Off Topic	Helmut	2020-08-31 15:33	0		477
Decision of confidence interval of three period BE study Two tests and one reference Two tests and one reference Two tests and one reference Two regions: No α adjustment Two regions: No α adjustment Two regions: different populations Decision of confidence interval of three period BE study Any of two tests and one reference Any of two tests and one reference Hey wait a moment.... Hey wait a moment.... Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Pilot or pivotal ? Hey, hey wait another moment.... Hey, hey wait another moment.... Old belives die hard	General Statistics	libaiyi	2018-06-26 12:00	23	2020-08-31 11:26	9,245
EMA dataset I, can someone post results? EMA dataset I, can someone post results? EMA dataset I, can someone post results? EMA dataset I (PHX/WNL 8.1) EMA dataset I (PHX/WNL 8.1) EMA dataset I (PHX/WNL 8.1) EMA dataset I (PHX/WNL 8.1)	General Statistics	ElMaestro	2020-08-14 20:54	6	2020-08-20 01:05	1,581
Partial replicate design: reference(s)? Partial replicate design: reference(s)? Partial replicate design: reference(s)? Hyslop's Alternative Cross-over Designs for Individual Bioequivalence Terry’s homebrew impressive homebrew impressive indeed Partial replicate design: reference(s)? Donald’s model Donald’s model - model for (logistic) groups Donald’s model - model for (logistic) groups Interlude I (sample sizes, problems & remedies) Interlude II (simulations) Interlude II (simulations)	RSABE / ABEL	Helmut	2020-08-13 14:22	13	2020-08-19 22:26	2,465
Metformin Bioequivalence Study	Design Issues	AB661	2020-08-19 09:22	0		575