Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Validation of Progesterone Validation of Progesterone Validation of Progesterone	Compliance	2013-09-10 10:13	2	2013-10-19 06:53	5,087
Analyte measured to Lymecycline bioequivalence study Analyte measured to Lymecycline bioequivalence study Analyte measured to Lymecycline bioequivalence study Analyte measured to Lymecycline bioequivalence study Analyte measured to Lymecycline bioequivalence study Analyte measured to Lymecycline bioequivalence study	Mauricio Sampaio	2013-09-02 15:50	5	2013-09-05 03:54	10,628
Freeze-thaw studies Freeze-thaw studies Freeze-thaw studies Freeze-thaw studies	martin	2013-09-04 11:29	3	2013-09-04 12:43	6,261
selection of appropriate matrix for BA/BE studies Mainly plasma Mainly plasma Mainly plasma	saipraveen7	2013-07-24 16:45	3	2013-07-24 22:05	5,402
Levothyroxine	cakhatri	2013-06-05 19:11	0		3,004
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	6,826
Blood collection bag with EDTA anticoagulant	PM	2013-05-08 23:24	0		2,430
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	6,828
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	5,561
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	6,797
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	6,480
Aspirin estimation Aspirin estimation	Compliance	2013-01-29 08:02	1	2013-01-29 09:25	4,933
Matrix Effect	sick	2013-01-20 10:45	0		2,751
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	10,304
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	10,569