Biomarkers in Drug Discovery and Development: From Target Identification through Drug Marketing

Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework

2001 • 6,216 citations

Use of proteomic patterns in serum to identify ovarian cancer

2002 • 3,227 citations

Preliminary Report: Effect of Encainide and Flecainide on Mortality in a Randomized Trial of Arrhythmia Suppression after Myocardial Infarction

1989 • 3,227 citations

Surrogate endpoints in clinical trials: Definition and operational criteria

1989 • 1,929 citations

Proteomics and Bioinformatics Approaches for Identification of Serum Biomarkers to Detect Breast Cancer

2002 • 898 citations

The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data

2005 • 758 citations

Multimarker Approach to Risk Stratification in Non-ST Elevation Acute Coronary Syndromes

2002 • 738 citations

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

2000 • 562 citations

Use of Biomarkers and Surrogate Endpoints in Drug Development and Regulatory Decision Making: Criteria, Validation, Strategies

2001 • 459 citations

Association of Vascular Endothelial Growth Factor Expression with Tumor Angiogenesis and with Early Relapse in Primary Breast Cancer

1994 • 404 citations

Tumor angiogenesis in breast cancer: Its importance as a prognostic indicator and the association with vascular endothelial growth factor expression

1995 • 376 citations

Pharmacokinetic/Pharmacodynamic Modeling in Drug Development

2000 • 339 citations

The endogenous cannabinoid system and brain development

2000 • 338 citations

Tissue Microarray Sampling Strategy for Prostate Cancer Biomarker Analysis

2002 • 318 citations

The biology of the opioid growth factor receptor (OGFr)

2002 • 311 citations

Simulation of Clinical Trials

2000 • 280 citations

Basic concepts of pharmacokinetic/pharmacodynamic (PK/PD) modelling.

1997 • 261 citations

Pharmacokinetic/Pharmacodynamic Modeling in Drug Research and Development

2000 • 191 citations

Measurement of Urinary F2-Isoprostanes as Markers of in Vivo Lipid Peroxidation—A Comparison of Enzyme Immunoassay with Gas Chromatography/Mass Spectrometry

1999 • 180 citations

Handbook of Pharmaceutical Analysis

2001 • 124 citations

Measurement Validity in Physical Therapy Research

1993 • 115 citations

Role of modelling and simulation in Phase I drug development

2001 • 109 citations

Workshop on bioanalytical methods validation for macromolecules: summary report.

2001 • 108 citations

Validation of biomarkers as early predictors of disease

2001 • 107 citations

Pharmacokinetic-pharmacodynamic modelling of morphine transport across the blood-brain barrier as a cause of the antinociceptive effect delay in rats--a microdialysis study.

2000 • 105 citations

Toxicoproteomics — a new preclinical tool

2002 • 103 citations

Revisiting the anticardiolipin test and its standardization

2002 • 98 citations

A randomized, double‐blind trial of the effect of glucocorticoid, antileukotriene and bβ‐agonist treatment on IL‐10 serum levels in children with asthma

2002 • 97 citations

The contribution of clinical pharmacology surrogates and models to drug development—a critical appraisal

1997 • 94 citations

Agmatine: An Endogenous Ligand at Imidazoline Receptors Is a Novel Neurotransmitter^a

1999 • 90 citations

Pharmacometrics: modelling and simulation tools to improve decision making in clinical drug development

2000 • 88 citations

Optimizing the Use of Biomarkers, Surrogate Endpoints, and Clinical Endpoints for More Efficient Drug Development

2000 • 88 citations

Mechanism-based pharmacodynamic modeling

1994 • 83 citations

EVALUATION OF TUMOUR ANGIOGENESIS AS A PROGNOSTIC MARKER IN MALIGNANT MESOTHELIOMA

1997 • 81 citations

Clinical trial simulation of docetaxel in patients with cancer as a tool for dosage optimization

2000 • 77 citations

An Approach to the Validation of Markers for Use in AIDS Clinical Trials

1997 • 76 citations

Molecular Forms of Prostate-specific Antigen in Malignant and Benign Prostatic Tissue: Biochemical and Diagnostic Implications

2000 • 72 citations

Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model

2000 • 70 citations

A Pearson‐type goodness‐of‐fit test for stationary and time‐continuous Markov regression models

2002 • 63 citations

A phase II study of razoxane, an antiangiogenic topoisomerase II inhibitor, in renal cell cancer with assessment of potential surrogate markers of angiogenesis.

2000 • 62 citations

Ligands for the Benzodiazepine Binding Site - a Survey

1999 • 56 citations

Differences between local investigator and core laboratory interpretation of the admission electrocardiogram in patients with unstable angina pectoris or non–q-wave myocardial infarction (a thrombin inhibition in myocardial ischemia [trim] substudy)

1998 • 52 citations

Pharmacokinetic/pharmacodynamic modeling of antitumor agents encapsulated into liposomes

1999 • 48 citations

Selecting and Validating Biologic Markers for Drug Development

1997 • 45 citations

Acute Migraine Treatment Outcome Measures: A Clinician's View

2000 • 43 citations

Reliability and validity of serum sex hormone measurements.

1996 • 42 citations

Flow Cytometric Microsphere-Based Immunoassay: Analysis of Secreted Cytokines in Whole-Blood Samples from Asthmatics

2001 • 42 citations

Cryopreserving whole blood for functional assays using viable lymphocytes in molecular epidemiology studies

2001 • 38 citations

Reduced Interleukin-18 Levels in BAL Specimens From Patients With Asthma Compared to Patients With Sarcoidosis and Healthy Control Subjects

2002 • 38 citations

Sensitivity analysis of pharmacokinetic and pharmacodynamic systems: I. A structural approach to sensitivity analysis of physiologically based pharmacokinetic models.

1999 • 36 citations

A sensitive fluorometric enzyme-linked immunosorbent assay that measures vascular endothelial growth factor165 in human plasma

1998 • 33 citations

Surrogate Biochemical Markers: Precise Measurement for Strategic Drug and Biologics Development

1995 • 31 citations

Common practice in molecular biology may introduce statistical bias and misleading biological interpretation

2002 • 29 citations

A regulatory perspective on pharmacokinetic/pharmacodynamic modelling

1999 • 29 citations

Pharmacodynamic Modeling of Lansoprazole Using an Indirect Irreversible Response Model

2001 • 28 citations

One core laboratory at two international sites, is that feasible? An inter‐core laboratory and intra‐observer variability study

2002 • 27 citations

Searching for Pharmacogenomic Markers: The Synergy between Omic and Hypothesis-Driven Research

2001 • 26 citations

Measuring asthma control

2001 • 26 citations

Section 1C: Assessment of the functional activity and IgG Fc receptor utilisation of 64 IgG Rh monoclonal antibodies. Coordinator’s report

2002 • 25 citations

A regulatory perspective on pharmacokinetic/pharmacodynamic modelling

1999 • 22 citations

Strategies for genetic mapping of categorical traits.

2000 • 22 citations

Mechanism-based PK/PD model for the lymphocytopenia induced by endogenous and exogenous corticosteroids.

1999 • 21 citations

Can pharmacogenomics make a difference in drug development?

1999 • 20 citations

Early clinical trials of chemopreventive and biologic agents: Designs, populations, and endpoints

2001 • 19 citations

Biomarkers in Clinical Drug Development

2003 • 17 citations

On the Standardization of Total Prostate-Specific Antigen: an Exercise with Two Reference Preparations

1999 • 17 citations

Interferon-γsecretion of peripheral blood CD8+ T lymphocytes in patients with bronchial asthma:In vitrostimulus determines cytokine production

2001 • 14 citations

Standardization, analytical validation, and quality control of intermediate endpoint biomarkers

2001 • 14 citations

Serum biomarkers of non-neuron-endocrine origin in small-cell lung cancer: a 16-year study on carcinoembryonic antigen, tissue polypeptide antigen and lactate dehydrogenase

2000 • 13 citations

Pharmacokinetic‐pharmacodynamic modelling in the early development phase of anti‐psychotics: a comparison of the effects of clozapine, S 16924 and S 18327 in the EEG model in rats

2001 • 12 citations

Functional Analysis of Chromatin Assembled in Synthetic Nuclei

1999 • 11 citations

Quantitative Measurements of Medical Images for Pharmaceutical Clinical Trials

2000 • 11 citations

[Biological markers: utilization in drug development and approval].

2001 • 10 citations

The evolution of knowledge on the pathophysiology of portal hypertension.

1996 • 10 citations

Drugs and Endogenous Ligands Compete for Receptor Occupancy

1994 • 9 citations

Evaluation of semi-quantitative methods for protein and sugar estimation in urine.

2001 • 7 citations

Methodological aspects in the analysis of spontaneously produced sputum.

2001 • 5 citations

Validation of markers for their relevance to health and disease.

2000 • 4 citations