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PubPharm (144)
1
2023 White Paper on Recent Issues in Bioanalysis : ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard
enthalten in:
Bioanalysis
| 2024
von
Mora, J.
|
Palmer, R.
|
Wagner, L.
| +55
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2
2022 White Paper on Recent Issues in Bioanalysis : ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (
enthalten in:
Bioanalysis
| 2023
von
Szapacs, M.
|
Jian, W.
|
Spellman, D.
| +83
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3
2022 White Paper on Recent Issues in Bioanalysis : Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles
enthalten in:
Bioanalysis
| 2023
von
Sumner, G.
|
Keller, S.
|
Huleatt, J.
| +71
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4
2022 White Paper on Recent Issues in Bioanalysis : FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (
enthalten in:
Bioanalysis
| 2023
von
Pan, L.
|
Mora, J.
|
Walravens, K.
| +66
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5
2021 White Paper on Recent Issues in Bioanalysis : TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (
enthalten in:
Bioanalysis
| 2022
von
Loo, L.
|
Harris, S.
|
Milton, M.
| +59
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6
Recommendations on qPCR/ddPCR assay validation by GCC
enthalten in:
Bioanalysis
| 2022
von
Wissel, M.
|
Poirier, M.
|
Satterwhite, C.
| +41
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7
2021 White Paper on Recent Issues in Bioanalysis : ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (
enthalten in:
Bioanalysis
| 2022
von
Hersey, S.
|
Keller, S.
|
Mathews, J.
| +68
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8
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2– Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)
enthalten in:
Bioanalysis
| 2022
von
Hersey, S.
|
Keller, S.
|
Mathews, J.
| +68
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9
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3– Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)
enthalten in:
Bioanalysis
| 2022
von
Loo, L.
|
Harris, S.
|
Milton, M.
| +58
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10
Recommendations on qPCR/ddPCR assay validation by GCC
enthalten in:
Bioanalysis
| 2022
von
Wissel, M.
|
Poirier, M.
|
Satterwhite, C.
| +41
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Indian journal of dermatology
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bioanalysis
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immunogenicity
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