Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax BE assessment regarding first time point Cmax FDA and outliers	Mann	2018-12-09 10:14	4	2018-12-11 16:38	347
subject withdrawn after bioanalysis Cherry-picking? Cherry-picking?	anbu	2018-09-12 10:17	2	2018-09-12 13:17	563
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	923
Definition of Enrolled subject Definition of Enrolled subject Definition of Enrolled subject	jag009	2018-07-11 21:27	2	2018-07-17 06:36	887
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	1,059
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	1,175
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	2,290
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	4,890
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	3,117
Ever handled the "wrong treatment" in a PK?	Relaxation	2018-01-26 18:31	0		837
risk management	Norah	2018-01-22 13:53	0		664
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	4,198
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	2,493
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	2,896
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	2,869
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	4,797

Bioequivalence and Bioavailability Forum 04:11 CET