Fit-for-purpose biomarker method validation in anticancer drug development.

[1]  P. Workman,et al.  Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development? , 2010, Drug discovery today.

[2]  D. Hodgson,et al.  Circulating tumour-derived predictive biomarkers in oncology. , 2010, Drug discovery today.

[3]  M. Ranson,et al.  Detection of PIK3CA mutations in circulating free DNA in patients with breast cancer , 2010, Breast Cancer Research and Treatment.

[4]  M. Gulley,et al.  Recommended principles and practices for validating clinical molecular pathology tests. , 2009, Archives of pathology & laboratory medicine.

[5]  Hanns-Christian Mahler,et al.  Protein aggregation: pathways, induction factors and analysis. , 2009, Journal of pharmaceutical sciences.

[6]  J. Davagnino,et al.  Effects of pH and arginine on the solubility and stability of a therapeutic protein (Fibroblast Growth Factor 20): relationship between solubility and stability. , 2009, Current pharmaceutical biotechnology.

[7]  Serge Rudaz,et al.  A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation. , 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[8]  Caroline Dive,et al.  Tumorigenesis and Neoplastic Progression Evaluation of Circulating Tumor Cells and Serological Cell Death Biomarkers in Small Cell Lung Cancer Patients Undergoing Chemotherapy , 2010 .

[9]  J. W. Findlay,et al.  Some important considerations for validation of ligand-binding assays. , 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[10]  Stuart McDougall,et al.  Statistical methods for assessing long-term analyte stability in biological matrices. , 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[11]  Dushyant V. Sahani,et al.  Biomarkers of response and resistance to antiangiogenic therapy , 2009, Nature Reviews Clinical Oncology.

[12]  T. Veenstra,et al.  Quantitative analysis of biomarkers by LC-MS/MS. , 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[13]  Anthony J. DeStefano,et al.  Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations , 2009, The AAPS Journal.

[14]  Aleksander S. Popel,et al.  A Compartment Model of VEGF Distribution in Humans in the Presence of Soluble VEGF Receptor-1 Acting as a Ligand Trap , 2009, PloS one.

[15]  Stephen J. Morris,et al.  Phase I trial of AEG35156 administered as a 7-day and 3-day continuous intravenous infusion in patients with advanced refractory cancer. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[16]  G. Jayson,et al.  'Fit-for-purpose' validation of SearchLight multiplex ELISAs of angiogenesis for clinical trial use. , 2009, Journal of immunological methods.

[17]  Lisa M. McShane,et al.  Effective Incorporation of Biomarkers into Phase II Trials , 2009, Clinical Cancer Research.

[18]  S. Kaye,et al.  From Darkness to Light With Biomarkers in Early Clinical Trials of Cancer Drugs , 2009, Clinical pharmacology and therapeutics.

[19]  M Laurentie,et al.  Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal part IV. Examples of application. , 2008, Journal of pharmaceutical and biomedical analysis.

[20]  William D. Figg,et al.  Validation of Analytic Methods for Biomarkers Used in Drug Development , 2008, Clinical Cancer Research.

[21]  J. W. Findlay,et al.  Specificity and Accuracy Data for Ligand-binding Assays for Macromolecules Should be Interpreted with Caution , 2008, The AAPS Journal.

[22]  M. Ranson,et al.  Optimisation of circulating biomarkers of cell death for routine clinical use. , 2008, Annals of oncology : official journal of the European Society for Medical Oncology.

[23]  Richard C Zangar,et al.  Development and validation of sandwich ELISA microarrays with minimal assay interference. , 2008, Journal of proteome research.

[24]  M. Ranson,et al.  Multiplexed assays for detection of mutations in PIK3CA. , 2008, Clinical chemistry.

[25]  J Cummings,et al.  Biomarker method validation in anticancer drug development , 2008, British journal of pharmacology.

[26]  C. Wagner,et al.  Simultaneous Detection of Eight Analytes in Human Serum by Two Commercially Available Platforms for Multiplex Cytokine Analysis , 2007, Clinical and Vaccine Immunology.

[27]  Patrice Chiap,et al.  Harmonization of strategies for the validation of quantitative analytical procedures , 2007 .

[28]  C. Fenselau A review of quantitative methods for proteomic studies. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[29]  Max Feinberg,et al.  Validation of analytical methods based on accuracy profiles. , 2007, Journal of chromatography. A.

[30]  P. Hubert,et al.  Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept. , 2007, Journal of chromatography. A.

[31]  Binodh DeSilva,et al.  Key elements of bioanalytical method validation for macromolecules , 2007, The AAPS Journal.

[32]  Howard M. Hill,et al.  Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies , 2007, The AAPS Journal.

[33]  Eric Woolf,et al.  Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples , 2007, The AAPS Journal.

[34]  Surendra Bansal,et al.  Key elements of bioanalytical method validation for small molecules , 2007, The AAPS Journal.

[35]  Vinod P. Shah,et al.  The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation , 2007, The AAPS Journal.

[36]  M. Ranson,et al.  Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma , 2007, Cancer Chemotherapy and Pharmacology.

[37]  Olaf H Drummer,et al.  Validation of new methods. , 2007, Forensic science international.

[38]  J. Wagner,et al.  Biomarkers and Surrogate End Points for Fit‐for‐Purpose Development and Regulatory Evaluation of New Drugs , 2007, Clinical pharmacology and therapeutics.

[39]  Claude Ricks,et al.  Multiplexing molecular diagnostics and immunoassays using emerging microarray technologies , 2007, Expert review of molecular diagnostics.

[40]  Paul Hasler,et al.  Protein microarray platform for the multiplex analysis of biomarkers in human sera. , 2006, Journal of immunological methods.

[41]  K. Feldmann,et al.  Early and Specific Prediction of the Therapeutic Efficacy in Non–Small Cell Lung Cancer Patients by Nucleosomal DNA and Cytokeratin‐19 Fragments , 2006, Annals of the New York Academy of Sciences.

[42]  S. Srivastava,et al.  Joint National Cancer Institute-Food and Drug Administration Workshop on Research Strategies, Study Designs, and Statistical Approaches to Biomarker Validation for Cancer Diagnosis and Detection , 2006, Cancer Epidemiology Biomarkers & Prevention.

[43]  N. Dalay,et al.  Circulating fragmented nucleosomal DNA and caspase-3 mRNA in patients with lymphoma and myeloma. , 2006, Experimental and molecular pathology.

[44]  Viswanath Devanarayan,et al.  Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.

[45]  J. Weinstein,et al.  Biomarkers in Cancer Staging, Prognosis and Treatment Selection , 2005, Nature Reviews Cancer.

[46]  Binodh DeSilva,et al.  Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies , 2005, Pharmaceutical Research.

[47]  H. Soares,et al.  Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report , 2005, Pharmaceutical Research.

[48]  C. Sigman,et al.  New science-based endpoints to accelerate oncology drug development. , 2005, European journal of cancer.

[49]  Leonard Steinborn,et al.  International Organization for Standardization ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories , 2004 .

[50]  M Laurentie,et al.  Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II. , 2004, Journal of pharmaceutical and biomedical analysis.

[51]  K. Feldmann,et al.  Circulating Nucleosomes Predict the Response to Chemotherapy in Patients with Advanced Non–Small Cell Lung Cancer , 2004, Clinical Cancer Research.

[52]  Philippe Hubert,et al.  New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data , 2004, Analytical and bioanalytical chemistry.

[53]  I. Kola,et al.  Can the pharmaceutical industry reduce attrition rates? , 2004, Nature Reviews Drug Discovery.

[54]  George G Klee,et al.  Absolute quantification of the model biomarker prostate-specific antigen in serum by LC-Ms/MS using protein cleavage and isotope dilution mass spectrometry. , 2004, Journal of proteome research.

[55]  Binodh DeSilva,et al.  Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules , 2003, Pharmaceutical Research.

[56]  P. Chiap,et al.  An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progress and limitations. , 2003, Journal of pharmaceutical and biomedical analysis.

[57]  I. Nilsson,et al.  Sample handling and stability of hepatocyte growth factor in blood samples. , 2002, Cytokine.

[58]  Krys J. Miller,et al.  Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report , 2001, Pharmaceutical Research.

[59]  M. Untch,et al.  Nucleosomes in Serum as a Marker for Cell Death , 2001, Clinical chemistry and laboratory medicine.

[60]  M S Pepe,et al.  Phases of biomarker development for early detection of cancer. , 2001, Journal of the National Cancer Institute.

[61]  M. Untch,et al.  Nucleosomes in serum of patients with benign and malignant diseases , 2001, International journal of cancer.

[62]  Vinod P. Shah,et al.  Bioanalytical Method Validation—A Revisit with a Decade of Progress , 2000, Pharmaceutical Research.

[63]  R. Detels,et al.  Variables That Affect Assays for Plasma Cytokines and Soluble Activation Markers , 1999, Clinical Diagnostic Laboratory Immunology.

[64]  J. Westgard Selecting appropriate quality-control rules. , 1994, Clinical chemistry.

[65]  Thomas Layloff,et al.  Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies , 1992, Pharmaceutical Research.

[66]  A Yacobi,et al.  Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies , 1991, European Journal of Drug Metabolism and Pharmacokinetics.

[67]  Ferdousi Chowdhury,et al.  Validation and comparison of two multiplex technologies, Luminex and Mesoscale Discovery, for human cytokine profiling. , 2009, Journal of immunological methods.

[68]  Daniel Figeys,et al.  Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkers. , 2007, Advances in cancer research.

[69]  Katerina Oikonomopoulou,et al.  Mass spectrometry: uncovering the cancer proteome for diagnostics. , 2007, Advances in cancer research.

[70]  C. T. Viswanathan,et al.  Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays , 2007, Pharmaceutical Research.

[71]  M Laurentie,et al.  Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III. , 2007, Journal of pharmaceutical and biomedical analysis.

[72]  Staðlaráð Íslands,et al.  Gæðastjórnunarkerfi : grunnatriði og íðorðasafn = Quality Management Systems : fundamentals and vocabulary. , 2006 .

[73]  E. Thorland,et al.  Preclinical validation of fluorescence in situ hybridization assays for clinical practice , 2006, Genetics in Medicine.

[74]  M Laurentie,et al.  Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--Part I. , 2004, Journal of pharmaceutical and biomedical analysis.

[75]  E. Zerhouni,et al.  Medicine. The NIH Roadmap. , 2003, Science.

[76]  J. W. Findlay,et al.  Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. , 2000, Journal of pharmaceutical and biomedical analysis.