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PubPharm (53)
1
Considerations for drug development biomarker assays in the clinical laboratory
enthalten in:
Bioanalysis
| 2023
von
Arnold, M.
|
Allinson, J.
|
Piccoli, S.
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2
Plasma and cerebrospinal fluid pharmacokinetics of vodobatinib, a neuroprotective c-Abl tyrosine kinase inhibitor for the treatment of Parkinson's disease
enthalten in:
Parkinsonism & related disorders
| 2023
von
Walsh, R.
|
Damle, N.
|
Mandhane, S.
| +6
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3
Identification of hnRNP-A1 as a pharmacodynamic biomarker of type I PRMT inhibition in blood and tumor tissues
enthalten in:
Scientific reports
| 2020
von
Noto, P.
|
Sikorski, T.
|
Zappacosta, F.
| +9
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4
2019 White Paper on Recent Issues in Bioanalysis : FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
enthalten in:
Bioanalysis
| 2019
von
Piccoli, S.
|
Mehta, D.
|
Vitaliti, A.
| +72
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5
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
enthalten in:
Bioanalysis
| 2019
von
Piccoli, S.
|
Mehta, D.
|
Vitaliti, A.
| +72
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6
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)
enthalten in:
Bioanalysis
| 2018
von
Neubert, H.
|
Olah, T.
|
Lee, A.
| +44
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7
2018 White Paper on Recent Issues in Bioanalysis : focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
enthalten in:
Bioanalysis
| 2018
von
Stevenson, L.
|
Richards, S.
|
Pillutla, R.
| +69
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8
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)
enthalten in:
Bioanalysis
| 2018
von
Welink, J.
|
Xu, Y.
|
Yang, E.
| +50
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9
The FDA/critical path initiative/Duke-Margolis center for health policy public workshop on analytical validation of assays for biomarker qualification : an update on the White Paper
enthalten in:
Bioanalysis
| 2018
von
Piccoli, S.
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10
Biomarker assay validation
enthalten in:
Bioanalysis
| 2018
von
Piccoli, S.
|
Garofolo, F.
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