Bioequivalence and Bioavailability Forum

Subject	Author	posted	R’s	last reply	V’s
Marginally failed study for Europe Marginally failed study for Europe Upper 90% CL 0.17% > U	balakotu	2018-04-24 07:30	2	2018-04-29 23:46	612
Outlier in BE Low AUC after reference product Low AUC after reference product Outlier in BE Outlier in BE Outlier in BE	ramgopi	2018-03-14 11:29	5	2018-03-19 10:55	1,367
When the the infusion speed deviate from the protocol specified Different PK profile Different PK profile Different PK profile Different PK profile Suitable equipment? Suitable equipment? AUC=f·D/CL AUC=f·D/CL AUC=f·D/CL AUC=f·D/CL When the the infusion speed deviate from the protocol specified When the the infusion speed deviate from the protocol specified	ssussu	2018-02-06 10:48	12	2018-02-09 00:31	1,526
CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total?	Elena777	2018-01-20 12:31	9	2018-02-07 20:31	1,842
Ever handled the "wrong treatment" in a PK?	Relaxation	2018-01-26 18:31	0		632
risk management	Norah	2018-01-22 13:53	0		446
ULOQ ULOQ ULOQ ULOQ ULOQ Not excluding invalid data? Excluding invalid data ULOQ Serial dilutions? Don’t!	Anand	2017-10-30 06:38	8	2017-10-30 18:03	1,913
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 05:42	1,362
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 11:05	1,649
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	1,692
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	2,495
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	7,988
Vasoconstriction Study	Research Scientist	2017-05-20 11:36	0		702
Bayesian BE Assessment Bayesian BE Assessment	Ben	2017-03-13 18:55	1	2017-03-14 11:45	939
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	4,154
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	4,347