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Seongeun (Julia) Cho

Silver Spring Networks

8

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Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.

2021 Clinical Pharmacology & Therapeutics
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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)

2019 Bioanalysis
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Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis

2019 Bioanalysis
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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

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: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)

2017 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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