Hanna Ritzén

Recommendations on qPCR/ddPCR Assay Validation by GCC

Mark Wissel, Martin Poirier, Christina Satterwhite et al. · Bioanalysis · 2022 · 47 citations

Engineering, Immunology, Diagnosis +19

9th GCC Closed Forum: Capa in Regulated Bioanalysis; Method Robustness, Biosimilars, Preclinical Method Validation, Endogenous Biomarkers, Whole Blood Stability, Regulatory Audit Experiences and Electronic Laboratory Notebooks

Richard LeLacheur, Isabelle Dumont, Philippe Couerbe et al. · Bioanalysis · 2016 · 16 citations · Full text

Engineering, Electronic Laboratory Notebooks, Biomarker (Medicine) +24

The 10th GCC Closed Forum: Rejected Data, GCP in Bioanalysis, Extract Stability, BAV, Processed Batch Acceptance, Matrix Stability, Critical Reagents, Eln and Data Integrity and Counteracting Fraud

Stephanie Cape, Rafiq Islam, Corey Nehls et al. · Bioanalysis · 2017 · 15 citations · Full text

Preclinical Therapeutics, Matrix Stability, Global Cro Council +28

Recommendations for Classification of Commercial LBA Kits for Biomarkers in Drug Development From the GCC for Bioanalysis

Rafiq Islam, Sumit Kar, Hanna Ritzén et al. · Bioanalysis · 2019 · 14 citations · Full text

Engineering, Immunology, Gcc Recommendations +25

12th GCC Closed Forum: Critical Reagents; Oligonucleotides; CoA; Method Transfer; HRMS; Flow Cytometry; Regulatory Findings; Stability and Immunogenicity

Chad Briscoe, Nicola Hughes, Rafiq Islam et al. · Bioanalysis · 2019 · 13 citations · Full text

Regulatory Issues, Immunohematology, Engineering +30