Marianne S. Fjording

Malov, Denmark

Last Updated: 09/26/2026

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Found 18 publications

Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion.

Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion.

Journal: Bioanalysis
Published: November 07, 2024

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).

Journal: Bioanalysis
Published: August 31, 2023

Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.

Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.

Journal: Bioanalysis
Published: July 29, 2022

Recommendations on qPCR/ddPCR assay validation by GCC.

Recommendations on qPCR/ddPCR assay validation by GCC.

Journal: Bioanalysis
Published: June 15, 2022

Recommendations on ELISpot assay validation by the GCC.

Recommendations on ELISpot assay validation by the GCC.

Journal: Bioanalysis
Published: February 09, 2022

EBF recommendation on practical management of critical reagents for PK ligand-binding assays.

EBF recommendation on practical management of critical reagents for PK ligand-binding assays.

Journal: Bioanalysis
Published: September 19, 2018

Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum.

Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum.

Journal: Bioanalysis
Published: August 22, 2018

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.

Journal: Bioanalysis
Published: January 19, 2018

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

Journal: Bioanalysis
Published: December 06, 2017

Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective.

Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective.

Journal: Bioanalysis
Published: October 24, 2017

C5a and C5aR are elevated in joints of rheumatoid and psoriatic arthritis patients, and C5aR blockade attenuates leukocyte migration to synovial fluid.

C5a and C5aR are elevated in joints of rheumatoid and psoriatic arthritis patients, and C5aR blockade attenuates leukocyte migration to synovial fluid.

Journal: PloS one
Published: September 15, 2017

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.

Journal: Bioanalysis
Published: August 03, 2017
Showing 1-12 of 18

Last Updated: 09/26/2026