Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics

“Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical Studies

(2009) Jin Wang et al.   AAPS Journal

Tartrate-resistant acid phosphatase (TRACP 5b): A biomarker of bone resorption rate in support of drug development: Modification, validation and application of the BoneTRAP® kit assay

(2009) Yuling Wu et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development of a method for the sensitive and quantitative determination of hepcidin in human serum using LC-MS/MS

(2009) Hongyan Li et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Validation of Analytic Methods for Biomarkers Used in Drug Development

(2008) C. H. Chau et al.   CLINICAL CANCER RESEARCH

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis☆

(2008) Jean W. Lee et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Using Predictive Biomarkers to Select Patients With Advanced Colorectal Cancer for Treatment With Epidermal Growth Factor Receptor Antibodies

(2008) Rachel Wong et al.   JOURNAL OF CLINICAL ONCOLOGY

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor κB ligand

(2008) Ronald R. Bowsher et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Strategic paths for biomarker qualification

(2008) Federico M. Goodsaid et al.   TOXICOLOGY

Biomarker method validation in anticancer drug development

(2007) J Cummings et al.   BRITISH JOURNAL OF PHARMACOLOGY