Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
BLQ handling in BE study where all values in one profile are BLQ BLQ handling in BE study where all values in one profile are BLQ all values in one profile are BLQ (test) BLQ handling in BE study where all values in one profile are BLQ BLQ handling in BE study where all values in one profile are BLQ	Hutchy_7	2019-11-28 15:17	4	2019-11-28 17:44	474
“Average” plots “Average” plots “Average” plots Three shades of red Three shades of red Three shades of red Three shades of red	Helmut	2019-04-25 19:06	6	2019-04-26 18:27	1,376
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 17:05	2,524
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	8,455
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	8,280
Baseline correction method Baseline correction method Baseline correction method	Sundar.M	2019-01-07 13:54	2	2019-01-08 17:42	1,172
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	1,294
PK parameters Good reporting practices	lakshmiprasad	2018-05-17 06:55	1	2018-05-17 13:20	1,292
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	11,867
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	2,049
BLLOQ (or NQ-Non Quantifiable Concentrations) in PK Concentration data	Ashwitha	2017-07-09 15:02	0		1,480
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	20,430
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	3,813
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	4,216
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	4,097