Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
subject withdrawn after bioanalysis Cherry-picking? Cherry-picking?	anbu	2018-09-12 10:17	2	2018-09-12 13:17	453
Cmax is out of the range Bad luck Bad luck Cherry-picking Cmax is out of the range	Mikalai	2018-08-01 12:05	4	2018-08-02 17:56	800
Definition of Enrolled subject Definition of Enrolled subject Definition of Enrolled subject	jag009	2018-07-11 21:27	2	2018-07-17 06:36	822
BE/BA centers BE/BA centers BE/BA centers BE/BA centers BE/BA centers BE/BA centers	JLpiccard	2018-07-13 20:35	5	2018-07-16 18:51	963
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	1,080
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	2,105
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	4,510
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	2,824
Ever handled the "wrong treatment" in a PK?	Relaxation	2018-01-26 18:31	0		809
risk management	Norah	2018-01-22 13:53	0		630
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	3,740
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	2,310
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	2,639
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	2,637
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	4,478
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	9,387

Bioequivalence and Bioavailability Forum 19:09 CET