Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Simulation framework Simulation framework Conclusion Conclusion & beyond	Helmut	2019-04-15 12:08	14	2019-04-17 15:05	10,860
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 20:40	19,727
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 14:53	14,674
Baseline correction method Baseline correction method Baseline correction method	Sundar.M	2019-01-07 13:54	2	2019-01-08 16:42	4,644
Exclusion of PK parameters where less than 3 quantifiable concentrations Reliable estimates?	Babe_Ruth	2018-06-19 18:13	1	2018-06-19 23:12	4,435
PK parameters Good reporting practices	lakshmiprasad	2018-05-17 06:55	1	2018-05-17 11:20	4,318
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	2018-01-04 23:10	18,055
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 06:36	4,706
BLLOQ (or NQ-Non Quantifiable Concentrations) in PK Concentration data	Ashwitha	2017-07-09 15:02	0		3,455
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 10:32	6,523
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 06:50	6,480
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 06:01	6,543
How to decide partial AUC What ’bout science? What ’bout science? What ’bout science?	Compliance	2016-02-11 09:02	3	2016-02-16 12:12	7,332
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 21:46	9,210
Bi-/multiphasic MR Products – EMA MR-Guideline Bi-/multiphasic MR Products – EMA	beman	2015-10-19 12:31	1	2015-10-19 20:46	6,117