Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
AUC infinity AUC infinity: primary for the FDA AUC infinity: primary for the FDA AUC infinity: primary for the FDA	mokhtar saleh	2017-10-24 16:58	3	2017-10-27 03:42	8,837
Atorvastatin intra-subject Variability Atorvastatin intra-subject Variability Atorvastatin intra-subject Variability Atorvastatin intra-subject Variability	Amira	2017-09-26 12:26	3	2017-09-27 09:05	8,938
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 08:12	7,714
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 15:01	13,467
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 18:51	17,021
Vasoconstriction Study	Research Scientist	2017-05-20 11:36	0		2,762
Bayesian BE Assessment Bayesian BE Assessment	Ben	2017-03-13 18:55	1	2017-03-14 10:45	4,726
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 14:17	11,452
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 12:24	12,145
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 15:28	6,057
Pilot study assessment Nasty PE ⇒ reformulate… Pilot study assessment	Smog	2016-03-24 19:37	2	2016-03-27 16:07	7,804
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 08:44	9,265
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 06:53	10,641
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 06:02	23,464
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 16:02	10,543