Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Regulatives Submission Issues Regulatives Submission Issues Regulatives Submission Issues Regulatives Submission Issues Regulatives Submission Issues	balakotu	2014-05-19 14:06	4	2014-05-19 17:40	4,804
Subject did not swallow the tablets Subject did not swallow the tablets Subject did not swallow the tablets Subject did not swallow the tablets Subject did not swallow the tablets Subject did not swallow the tablets	Ken Peh	2014-06-20 05:53	5	2014-06-23 06:45	5,361
Revalidate the study Revalidate the study α ≠ β	Ken Peh	2014-07-20 19:01	2	2014-07-20 20:33	8,774
Borderline BE study Failure Borderline BE study Failure Borderline BE study Failure Interim analysis Borderline BE study Failure	Samaya B	2014-10-14 09:02	4	2014-10-15 13:29	8,337
Protocol deviation Protocol deviation	Ghousia Saba	2014-10-17 12:37	1	2014-10-17 13:48	5,474
BE study with two different batches of the reference product BE study with two different batches of the reference product BE study with two different batches of the reference product BE study with two different batches of the reference product Two different batches of R: bad idea Two different batches of R: Analysis separately?? Two different batches of R: very bad idea Forget it! Forget it! BE study with two different batches of the reference product BE study with two different batches of the reference product	tarak_desai	2014-12-16 06:51	10	2014-12-18 00:08	10,377
Submitting a pilot as a pivotal study Submitting a pilot as a pivotal study Submitting a pilot as a pivotal study pilot ≠ pivotal study Submitting a pilot as a pivotal study Submitting a pilot as a pivotal study	lechia	2015-04-06 16:14	5	2015-04-09 16:01	10,425
Esmeprazole Gastro resistant tablet BE study PE outside the acceptance range PE outside the acceptance range PE outside the acceptance range PE outside the acceptance range PE outside the acceptance range PE outside the acceptance range PE outside the acceptance range: end of the story PE outside the acceptance range	aanrin	2015-07-27 11:45	8	2015-08-24 13:43	11,796
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 11:19	8,205
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 15:57	7,601
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	8,625
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	19,995
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	8,455
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	7,614
Pilot study assessment Nasty PE ⇒ reformulate… Pilot study assessment	Smog	2016-03-24 19:37	2	2016-03-27 16:07	6,421