Comparison of three parallelism assessment methods of biomarker quantification by LC-MS/MS: a case study of the bioanalysis of creatinine in human urine samples

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

(2021) Hendrik Neubert et al.   Bioanalysis

Analytical method validation for biomarkers as a drug development tool: points to consider

(2021) Yoshiaki Ohtsu et al.   Bioanalysis

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)

(2019) Steven Piccoli et al.   Bioanalysis

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) Hendrik Neubert et al.   Bioanalysis

The Decennial Index of the White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

(2017) Wei Garofolo et al.   Bioanalysis

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) Jan Welink et al.   Bioanalysis

Quantitative analysis of endogenous compounds

(2016) Rhishikesh Thakare et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Parallelism experiments in biomarker ligand-binding assays to assess immunological similarity

(2016) Lindsay E King   Bioanalysis

Selecting the Correct Weighting Factors for Linear and Quadratic Calibration Curves with Least-Squares Regression Algorithm in Bioanalytical LC-MS/MS Assays and Impacts of Using Incorrect Weighting Factors on Curve Stability, Data Quality, and Assay Performance

(2014) Huidong Gu et al.   ANALYTICAL CHEMISTRY

Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules

(2012) Barry R Jones et al.   Bioanalysis

LC-MS-MS Measurements of Urinary Creatinine and the Application of Creatinine Normalization Technique on Cotinine in Smokers’ 24 Hour Urine

(2012) Hongwei Hou et al.   Journal of Analytical Methods in Chemistry