Recommendations on biomarker bioanalytical method validation by GCC

Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover

(2012) Steve Lowes et al.   Bioanalysis

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

(2012) Mark Boterman et al.   Bioanalysis

Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies

(2011) Marie-Anne Valentin et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Conference Report: The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum

(2011) Massimo Breda et al.   Bioanalysis

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

(2011) Steve Lowes et al.   Bioanalysis

Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs

(2010) J Cummings et al.   BRITISH JOURNAL OF CANCER

Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development

(2010) William Nowatzke et al.   Bioanalysis

Formation of a Global Contract Research Organization Council for Bioanalysis

(2010) Noel Premkumar et al.   Bioanalysis

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

Validation of Analytic Methods for Biomarkers Used in Drug Development

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