Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
FDA Recommendation on Matrix Effect Determination in CC Assay FDA Recommendation on Matrix Effect Determination in CC Assay FDA Recommendation on Matrix Effect Determination in CC Assay Reducing matrix effects	Obinoscopy	2018-10-01 14:38	3	2018-10-01 17:20	877
Spiramycine	giang nidqc	2018-09-27 08:55	0		429
LBAs Studies Forum policy	Dipal Patel	2018-09-25 14:33	1	2018-09-25 15:44	671
Stability of lysed whole blood or hemolyzed plasma	Ladi	2018-09-15 04:49	0		535
Simultaneous analytical method Simultaneous analytical method Simultaneous analytical method Simultaneous analytical method Simultaneous analytical method Simultaneous analytical method Simultaneous analytical method	giang nidqc	2018-09-10 09:39	6	2018-09-13 14:06	1,101
applying correction factor to unknown samples due to stabilization applying correction factor to unknown samples due to stabilization applying correction factor to unknown samples due to stabilization	Mithu	2018-09-06 10:27	2	2018-09-06 12:52	693
Determination of Indapamide concentration in plasma or whole blood? Determination of Indapamide concentration in plasma or whole blood? Determination of Indapamide concentration in plasma or whole blood? Determination of Indapamide concentration in plasma or whole blood? Determination of Indapamide concentration in plasma or whole blood?	gialuu	2018-08-30 10:55	4	2018-09-06 12:38	1,209
Calibrators & QCs requirement in all validation runs (latest USFDA BMV)	meet.shah	2018-09-05 09:19	0		491
Repeat based on ISR data investigation Repeat based on ISR data investigation Repeat based on ISR data investigation	Mithu	2018-08-08 10:09	2	2018-08-21 11:32	1,023
Blinding in Bioanalysis Blinding in Bioanalysis Not blinding sampling times Not blinding sampling times Blinding in Bioanalysis	Obinoscopy	2018-08-19 16:22	4	2018-08-19 22:20	1,108
Need of cross validation between 2 different cc range Need of cross validation between 2 different cc range Cross validation: same concentration range	Lmsmqa	2018-07-24 19:17	2	2018-07-25 12:39	798
Repeat analysis and re-injection of samples Sticking pump valves? Sticking pump valves?	Ladi	2018-07-14 06:09	2	2018-07-16 06:14	1,102
BA/BE study - internal standard response variability BA/BE study - internal standard response variability BA/BE study - internal standard response variability	avinash	2018-07-11 06:44	2	2018-07-12 00:24	1,039
Drug concentration <LLQ Drug concentration <LLQ Report as BLQ Report as BLQ Report as BLQ	GM	2018-06-29 05:47	4	2018-06-29 21:00	1,114
Freshly prepared Vs freshly spiked	Ramesh	2018-06-20 17:14	0		569
Selection of chromatograms and its programme 20% of randomly chosen chromatograms 20% of randomly chosen chromatograms 20% of randomly chosen chromatograms 20% of randomly chosen chromatograms - In any Guideline? 20% of randomly chosen chromatograms - In any Guideline? 20% of randomly chosen chromatograms - In any Guideline? Selection of chromatograms and its programme Selection of chromatograms and its programme Selection of chromatograms and its programme Selection of chromatograms and its programme Equal chance to every one Equal chance to every one Orphans, hats, bowls and urns Equal chance to every one NLYWs	Pandu	2009-02-23 14:00	15	2018-06-04 10:51	5,989

Bioequivalence and Bioavailability Forum 05:45 CET