Detalles de la búsqueda
1.
High-resolution isotope-dilution mass spectrometry using metabolism of isotope-labeled compounds: application to drug metabolites.
Rapid Commun Mass Spectrom;
26(22): 2569-76, 2012 Nov 30.
Artículo
en Inglés
| MEDLINE | ID: mdl-23059872
2.
Recommendations on qPCR/ddPCR assay validation by GCC.
Bioanalysis;
14(12): 853-863, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35703321
3.
Recommendations on ELISpot assay validation by the GCC.
Bioanalysis;
14(4): 187-193, 2022 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-35135309
4.
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bioanalysis;
13(8): 609-619, 2021 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-33847160
5.
Toward a smoke-free Harlem: engaging families, agencies, and community-based programs.
J Health Care Poor Underserved;
20(1): 107-21, 2009 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-19202251
6.
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Bioanalysis;
11(7): 645-653, 2019 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-30993999
7.
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Bioanalysis;
11(12): 1129-1138, 2019 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-31319683
8.
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Bioanalysis;
11(18s): 1-228, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31565956
9.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis;
11(23): 2099-2132, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31833782
10.
11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Bioanalysis;
10(7): 433-444, 2018 Apr 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29701066
11.
A sensitive liquid chromatography and mass spectrometry method for the determination of posaconazole in human plasma.
J Pharm Biomed Anal;
43(1): 228-36, 2007 Jan 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-16859858
12.
Evaluation of automated micro solid phase extraction tips (micro-SPE) for the validation of a LC-MS/MS bioanalytical method.
J Chromatogr B Analyt Technol Biomed Life Sci;
843(2): 275-82, 2006 Nov 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-16872919
13.
Orthogonal extraction/chromatography and UPLC, two powerful new techniques for bioanalytical quantitation of desloratadine and 3-hydroxydesloratadine at 25 pg/mL.
J Pharm Biomed Anal;
40(3): 689-706, 2006 Feb 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-16095862
14.
Novel techniques and the new age of biomarkers: panel discussion report.
Bioanalysis;
13(9): 675-678, 2021 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-33769091
15.
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Bioanalysis;
8(6): 487-95, 2016 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-26916197
16.
Minimization of ion suppression in LC-MS/MS analysis through the application of strong cation exchange solid-phase extraction (SCX-SPE).
J Pharm Biomed Anal;
37(2): 359-67, 2005 Feb 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-15708678
17.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
Bioanalysis;
7(22): 2913-25, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-26573485
18.
Contract research organization commentary on the importance of harmonization and the impact of ICH M10.
Bioanalysis;
11(18): 1727-1729, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31556330
19.
Recommendations on incurred sample stability (ISS) by GCC.
Bioanalysis;
6(18): 2385-90, 2014 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-25384591
20.
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Bioanalysis;
6(22): 3039-49, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25496256