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

Biomarker-Driven Early Clinical Trials in Oncology

(2010) Daniel S. W. Tan et al.   CANCER JOURNAL

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

(2009) Douglas M. Fast et al.   AAPS Journal

Evaluation of Circulating Tumor Cells and Serological Cell Death Biomarkers in Small Cell Lung Cancer Patients Undergoing Chemotherapy

(2009) Jian-Mei Hou et al.   AMERICAN JOURNAL OF PATHOLOGY

Effective Incorporation of Biomarkers into Phase II Trials

(2009) L. M. McShane et al.   CLINICAL CANCER RESEARCH

Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?

(2009) Craig P. Carden et al.   DRUG DISCOVERY TODAY

A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation

(2009) Bruno Boulanger et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Phase I Trial of AEG35156 Administered as a 7-Day and 3-Day Continuous Intravenous Infusion in Patients With Advanced Refractory Cancer

(2009) Emma Dean et al.   JOURNAL OF CLINICAL ONCOLOGY

Biomarkers of response and resistance to antiangiogenic therapy

(2009) Rakesh K. Jain et al.   Nature Reviews Clinical Oncology

Specificity and Accuracy Data for Ligand-binding Assays for Macromolecules Should be Interpreted with Caution

(2008) John W. A. Findlay   AAPS Journal

Optimisation of circulating biomarkers of cell death for routine clinical use

(2008) A. Greystoke et al.   ANNALS OF ONCOLOGY

Some important considerations for validation of ligand-binding assays

(2008) John W.A. Findlay   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Protein aggregation: Pathways, induction factors and analysis

(2008) Hanns-Christian Mahler et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Biomarker method validation in anticancer drug development

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