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1.
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.
Bioanalysis
; 16(5): 259-270, 2024 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-38315622
2.
Method establishment for discerned immunogenicity assessment of a recombinant glycoprotein containing nonhuman sialic acid Neu5Gc residues.
Bioanalysis
; 9(18): 1385-1393, 2017 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-28956633
3.
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bioanalysis
; 6(22): 2957-63, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25496252
4.
Recommendations on biomarker bioanalytical method validation by GCC.
Bioanalysis
; 4(20): 2439-46, 2012 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-23157353
5.
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Bioanalysis
; 4(17): 2117-26, 2012 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-23013394
6.
Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum.
Bioanalysis
; 3(24): 2721-7, 2011 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-22185271
7.
Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).
Bioanalysis
; 4(14): 1723-30, 2012 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-22877218
8.
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
Bioanalysis
; 4(6): 651-60, 2012 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-22452256
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