Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
BLQ considerations BLQ considerations ‘Embedded’ BQLs	Loky do	2022-03-28 12:16	2	2022-03-28 12:32	4,548
Analytical range LOQ Analytical range LOQ Analytical range LOQ Analytical range LOQ LLOQ based on ‘worst case’ Cmax LLOQ based on ‘worst case’ Cmax LLOQ based on ‘worst case’ Cmax	Farmacevt	2021-12-20 20:54	6	2021-12-22 22:16	6,061
GLP certification for Bioanalytical Lab. to conduct BA/BE studies. GLP certification for Bioanalytical Lab. to conduct BA/BE studies. GLP certification for Bioanalytical Lab. to conduct BA/BE studies.	Shreyas G	2021-12-17 21:22	2	2021-12-18 18:05	4,189
Manual integration Manual integration Manual integration	Helmut	2021-12-01 13:09	2	2021-12-01 16:38	4,311
Use of NP (Normal Phase) columns in bioanalysis Hydrophilic Interaction Liquid Chromatography Hydrophilic Interaction Liquid Chromatography	selwa ts	2021-11-17 11:04	2	2021-11-17 14:11	4,201
planning of bioequivalence sampling planning of bioequivalence sampling Challenge - something for the programmers here Really (really) tough stuff	selwa ts	2021-10-31 10:13	3	2021-11-07 22:33	4,613
dead / void volume dead / void volume	Bioanalytical	2021-10-03 16:28	1	2021-10-03 19:14	4,111
Suitability in bioanalysis Suitability in bioanalysis	selwa ts	2021-09-09 19:44	1	2021-09-09 21:09	3,817
Mean IS Variability consideration for Endogenous molecule-Stripped Matrix or BSA Mean IS Variability consideration for Endogenous molecule-Stripped Matrix or BSA	ksreekanth	2021-04-22 09:37	1	2021-04-29 04:06	3,882
Bioanalysis monitoring by sponsor Bioanalysis monitoring by sponsor Bioanalysis monitoring by sponsor Bioanalysis monitoring by sponsor Bioanalysis monitoring by sponsor	dshah	2021-03-02 16:19	4	2021-03-09 16:01	4,504
Different sampling time points and Blinding Different sampling time points and Blinding Different sampling time points and Blinding Different sampling time points and Blinding Different sampling time points and Blinding Blinding…	Pharma_88	2020-12-11 05:22	5	2020-12-12 11:06	4,634
Au sujet de la conservation du plasma frais congelé vierge Conservation du plasma frais congelé vierge - storage of blank plasma OT: Preferred language in the forum OT: Preferred language in the forum OT: Preferred language in the forum OT: Preferred language in the forum OT: Preferred language in the forum Just to annoy Helmut Easy, Fritz!	Developper bioanalyste	2020-10-14 16:33	8	2020-10-19 18:42	6,604
An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. Placement of CC An example of IS response. An example of IS response. Placement of CC Placement of CC Duplicate LLOQ and ULOQ Duplicate LLOQ and ULOQ An example of IS response. Need your helps. An example of IS response. Need your helps. Trend analysis as per recent USFDA guideline Only for QCs; encouraged ≠ required Only for QCs; encouraged ≠ required Deviation from the mean response Only for QCs; encouraged ≠ required Broken-stick regression	Shuanghe	2020-05-26 12:56	19	2020-08-07 11:28	15,013
dilution factor to be applied	avinash	2020-08-06 06:30	0		2,585
Reanalysis for Pharmacokinetic Reason Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind PK assessors variability Sometimes PK assessors ≈ scientists PK assessors variability Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Positive pre-dose Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Sightly OT (for once) Reanalysis for Pharmacokinetic Reason	Obinoscopy	2020-07-16 14:30	19	2020-07-27 21:47	12,039