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Rachel Green

Fordham University

10

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208

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Internal standards in regulated bioanalysis: putting in place a decision-making process during method development

2019 Bioanalysis
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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

2018 Bioanalysis
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2018 White Paper on Recent Issues in Bioanalysis: ‘A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)’ (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

2018 Bioanalysis
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2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

2017 Bioanalysis
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Recommendations on biomarker bioanalytical method validation by GCC

2012 Bioanalysis
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

2012 Bioanalysis
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Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)

2012 Bioanalysis
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Conference Report: The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum

2011 Bioanalysis
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