Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
PK profile outlier IS response? IS response? DB Summary Table 9 DB Summary Table 9	avinash	2013-05-02 14:48	4	2013-05-14 22:38	5,799
Blood collection bag with EDTA anticoagulant	PM	2013-05-08 23:24	0		1,975
dates in study plan of bioanalytical study dates in study plan of bioanalytical study dates in study plan of bioanalytical study dates in study plan of bioanalytical study dates in study plan of bioanalytical study	Ken Peh	2013-03-16 13:44	4	2013-03-20 15:45	5,953
Justification for the lack of ISR data Justification for the lack of ISR data Justification for the lack of ISR data	Dr Andrew Leary	2013-03-18 09:52	2	2013-03-18 12:02	4,762
Correct method for preparation of stock solution Volumetric flasks Volumetric flasks Volumetric flasks Correct method for preparation of stock solution A vote for both approaches	Ionsource	2013-03-11 17:25	5	2013-03-16 18:58	5,794
Difference in values between reanalysed and ISR samples Difference in values between reanalysed and ISR samples Difference in values between reanalysed and ISR samples Difference in values between reanalysed and ISR samples	cakhatri	2013-03-10 09:41	3	2013-03-16 13:40	5,312
Aspirin estimation Aspirin estimation	Compliance	2013-01-29 08:02	1	2013-01-29 09:25	4,297
Matrix Effect	sick	2013-01-20 10:45	0		2,406
FDA definition of non-accurately and reliably Experiences with EU submissions Experiences with EU submissions Experiences with EU submissions Experiences with EU submissions LLOQ “low enough”? LLOQ “low enough”? LLOQ “low enough”? LLOQ “low enough”?	jag009	2013-01-09 22:20	8	2013-01-11 19:14	9,153
Bioequivalence decision affected by ISR? Bioequivalence decision affected by ISR? Bioequivalence decision affected by ISR? Bioequivalence decision affected by ISR? Lousy studies? Tricky question Add'l requirements	Dr_Dan	2012-12-21 09:52	6	2012-12-23 04:10	9,339
ISR ISR ISR ISR ISR 90% CI riddle 90% CI riddle 90% CI riddle 90% CI riddle 90% CI riddle	The Outlaw Torn	2012-11-29 15:58	9	2012-12-20 11:58	10,783
Criterion for incurred samples Criterion for incurred samples	janmacek	2012-12-10 11:47	1	2012-12-10 11:37	3,527
Analytical error and its consequences Analytical error and its consequences CI of concentrations (quick & dirty R) CI of concentrations (quick & dirty R)	Helmut	2012-10-09 19:30	3	2012-10-16 02:45	6,677
Change in IS Change in IS	ketan	2012-10-12 08:57	1	2012-10-12 08:06	3,108
Causes of inconsistent recovery A manifold of potential causes & a story A manifold of potential causes & a story	Ionsource	2012-10-08 16:53	2	2012-10-09 06:50	3,762