Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
AUC0-tau at steady state AUC0-tau at steady state AUC0-tau at steady state RTFM RTFM AUC0-τ estimation with time deviations AUC0-τ estimation with time deviations Cτ for lin and lin-up/log-down Cτ by lin-/lin, lin-up/log-down, and λz inter- vs extra- inter- vs extra- No rule fits all one size fits all vs goal posts one size fits all vs goal posts Bias etc. software: NCA not validated no way out for NCA validation? Default rules	BNR	2016-03-31 22:46	17	2019-02-20 21:40	5,902
Steady state: Cmin / PTF Steady state: Cmin / PTF Steady state: Cmin / PTF Is Cmin an atavism or not? Originators \| generics (Cmin \| Cτ) Down with Big Brother Down with Big Brother thoughtcrime blackwhite animal farm	Helmut	2011-03-08 15:30	9	2019-02-04 15:53	5,483
Baseline correction method Baseline correction method Baseline correction method	Sundar.M	2019-01-07 13:54	2	2019-01-08 17:42	575
Exclusion of PK parameters where less than 3 quantifiable concentrations Reliable estimates?	Babe_Ruth	2018-06-19 18:13	1	2018-06-20 01:12	839
PK parameters Good reporting practices	lakshmiprasad	2018-05-17 06:55	1	2018-05-17 13:20	863
half-life in multiple-dosed steady-state BE/BA study? half-life in steady state; WinNonlin no lambda(z), no NCA? NCA without lambda(z) No rule is the rule - lambda(z) of MD BE Distinguish accumulation	yjlee168	2009-07-14 14:16	5	2018-01-05 00:10	10,603
calculation of cutoff time point in case of multiphasic modified release cutoff time point based on PK? cutoff time point based on PK?	Biostats	2017-11-25 09:22	2	2017-11-26 07:36	1,665
BLLOQ (or NQ-Non Quantifiable Concentrations) in PK Concentration data	Ashwitha	2017-07-09 15:02	0		1,232
Calculation of AUC0-72 Calculation of AUC0-72 Calculation of AUC0-72 Calculation of AUC0-72 Regulators truncated Regulators truncated Regulators truncated Regulators truncated Regulators truncated Regulators truncated Regulators truncated Luke 23:34 Calculation of AUC0-72 Calculation of AUC0-72 Calculation of AUC0-72 Calculation of AUC0-72 The missing 72h The missing 72h sensitivity analyses ? Regulators ways are inscrutable Regulators ways are inscrutable (at least the French) The missing 72h Page 3848 of 221 Partial AUC calculation Partial AUC calculation	Sasi	2008-06-10 10:44	24	2017-03-16 19:46	18,841
Which Tmax to be consider in case of b.i.d. dosing? Which Tmax to be consider in case of b.i.d. dosing? Which Tmax to be consider in case of b.i.d. dosing? Which Tmax to be consider in case of b.i.d. dosing? Which Tmax to be consider in case of b.i.d. dosing?	maulik963	2016-04-13 08:06	4	2016-04-16 12:32	3,463
0.00 concentration value between two measurable concentrations 0.00 concentration value between two measurable concentrations “Embedded BQLs” “Embedded BQLs”	arl_stat	2016-03-02 10:13	3	2016-04-15 08:50	3,953
t1/2 prior to Tmax in BE study t1/2 prior to Tmax in BE study t1/2 prior to Tmax in BE study t1/2 prior to Tmax in BE study	Dhruv Shah	2016-03-11 03:48	3	2016-03-16 07:01	3,786
How to decide partial AUC What ’bout science? What ’bout science? What ’bout science?	Compliance	2016-02-11 09:02	3	2016-02-16 13:12	3,877
Software validation Software validation Software validation Software validation Trilogy? Trilogy? Trilogy? Software validation Software validation	Helmut	2016-01-28 20:03	8	2016-01-29 22:46	4,624
Bi-/multiphasic MR Products – EMA MR-Guideline Bi-/multiphasic MR Products – EMA	beman	2015-10-19 12:31	1	2015-10-19 22:46	3,800

Bioequivalence and Bioavailability Forum 10:06 CET