Bioequivalence and Bioavailability Forum

Subject	Author	posted	R’s	last reply	V’s
EU ombudsman looking into EMA presubmission meetings EU ombudsman looking into EMA presubmission meetings EU ombudsman looking into EMA presubmission meetings EU ombudsman looking into EMA presubmission meetings	ElMaestro	2017-07-19 20:24	3	2017-07-20 10:12	210
Pivotal and pilot BE Study Pivotal and pilot BE Study Pivotal and pilot BE Study Pivotal and pilot BE Study Pivotal and pilot BE Study Retained samples?	K Vishal	2017-07-07 11:17	5	2017-07-08 17:01	476
Study Results Study Results upper CL < PE PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs GMR outside the limits when using ABEL Regulations ≠ Science Regulations ≠ Science	VSL	2015-04-20 21:46	10	2017-05-22 20:51	6,493
Vasoconstriction Study	Research Scientist	2017-05-20 11:36	0		312
Bayesian BE Assessment Bayesian BE Assessment	Ben	2017-03-13 18:55	1	2017-03-14 11:45	466
How to understand what is guilty? How to understand what is guilty? How to understand what is guilty? How to understand what is guilty? Post-hoc power is useless! Post-hoc power is useless! Post-hoc power is useless! Post-hoc power is useless! Post-hoc power is useless! Post-hoc power is useless!	BE-proff	2016-07-30 18:21	9	2016-08-09 16:17	2,710
hidden pill ? Let's reconnect with the real world, please Let's reconnect with the real world, please Let's reconnect with the real world, please Relax! Relax! Relax! Relax! Let's reconnect with the real world, please Let's reconnect with the real world, please Let's reconnect with the real world, please hidden pill ? hidden pill ?	Scientist fellow	2016-06-19 08:59	12	2016-07-06 14:24	2,988
Dose Proportionality and Variance More information, please More information, please Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Phoenix 64 Warning Phoenix 64 Warning OT: imperial vs. metric units Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin Setup in Phoenix/WinNonlin NCSS vs. PHX/WNL vs. SAS NCSS vs. PHX/WNL vs. SAS - Validation? Diagnostics Diagnostics: R and Phoenix Diagnostics: R Diagnostics: R SASian potpourri Compilation REML or not complete or not Compilation doubts about NCSS Doubts about NCSS Compilation Kenward-Roger? Smith’s paper	AngusMcLean	2016-05-11 16:55	28	2016-05-28 15:59	5,630
5% from Cmax/request from MoH RF 5% from Cmax/request from MoH RF "minimal average"??	Beholder	2016-05-23 16:23	2	2016-05-23 17:28	1,648
Pilot study assessment Nasty PE ⇒ reformulate… Pilot study assessment	Smog	2016-03-24 19:37	2	2016-03-27 18:07	2,758
if 75% of the subjects AUCt not covers at least 80% of AUCinf if 75% of the subjects AUCt not covers at least 80% of AUCinf Protocol / SAP? Protocol / SAP? if 75% of the subjects AUCt not covers at least 80% of AUCinf	rams	2016-03-15 06:38	4	2016-03-23 09:44	3,761
Missed tablets administration in a steady state study Missed tablets administration in a steady state study Missed tablets administration in a steady state study Missed tablets administration in a steady state study Missed tablets administration in a steady state study Missed tablets administration in a steady state study Missed tablets administration in a steady state study Missed tablets administration in a steady state study BE with PP-population BE with PP-population	BE-proff	2016-02-18 17:56	9	2016-02-25 07:53	3,517
Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study - same test? Approved Pilot and Failed Pivotal Study - same test? Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study Approved Pilot and Failed Pivotal Study	Lucas	2014-03-17 15:27	16	2015-12-08 07:02	8,582
How to use 2nd passed pivotal study after 1st pivotal failed How to use 2nd passed pivotal study after 1st pivotal failed How to use 2nd passed pivotal study after 1st pivotal failed 4-periods More information, please More information, please	Louis	2015-11-24 21:35	5	2015-11-27 17:02	3,809
2 way fasting and 3 way fed pilot results analysis 2 way fasting and 3 way fed pilot results analysis Where do these numbers come from? Numbers?	unique_one	2015-10-17 09:33	3	2015-11-23 16:57	3,727
Pilot Results and Pivotal Design Pilot Results and Pivotal Design Pilot Results and Pivotal Design HVD sample size	unique_one	2015-10-09 06:44	3	2015-10-09 13:19	4,183