Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development

Clinical pharmacology of AMG 181, a gut-specific human anti-α4β7monoclonal antibody, for treating inflammatory bowel diseases

(2014) Wei-Jian Pan et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

High-throughput flow cytometry data normalization for clinical trials

(2014) Greg Finak et al.   CYTOMETRY PART A

Highly multiplexed imaging of tumor tissues with subcellular resolution by mass cytometry

(2014) Charlotte Giesen et al.   NATURE METHODS

Compatibility of Stabilized Whole Blood Products with CD4 Technologies and Their Suitability for Quality Assessment Programs

(2014) Tao Ding et al.   PLoS One

Pharmacokinetics and Pharmacodynamics of ASKP1240, a Fully Human Anti-CD40 Antibody, in Normal and Renal Transplanted Cynomolgus Monkeys

(2014) Anlun Ma et al.   TRANSPLANTATION

Benralizumab, an anti-interleukin 5 receptor α monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study

(2014) Mario Castro et al.   Lancet Respiratory Medicine

Quantification of Expression of Antigens Targeted by Antibody-Based Therapy in Chronic Lymphocytic Leukemia

(2013) Prashant R. Tembhare et al.   AMERICAN JOURNAL OF CLINICAL PATHOLOGY

Anti-IL21 receptor monoclonal antibody (ATR-107): Safety, pharmacokinetics, and pharmacodynamic evaluation in healthy volunteers: A phase I, first-in-human study

(2013) Fei Hua et al.   JOURNAL OF CLINICAL PHARMACOLOGY

EGFR ligands as pharmacodynamic biomarkers in metastatic colorectal cancer patients treated with cetuximab and irinotecan

(2013) Fotios Loupakis et al.   Targeted Oncology

Brilliant violet fluorophores: A new class of ultrabright fluorescent compounds for immunofluorescence experiments

(2012) Pratip K. Chattopadhyay et al.   CYTOMETRY PART A

A randomised phase I study of etrolizumab (rhuMAb β7) in moderate to severe ulcerative colitis

(2012) Paul J Rutgeerts et al.   GUT

Tumor penetration and epidermal growth factor receptor saturation by panitumumab correlate with antitumor activity in a preclinical model of human cancer

(2012) Daniel J Freeman et al.   Molecular Cancer

Safety and Activity of Anti–PD-L1 Antibody in Patients with Advanced Cancer

(2012) Julie R. Brahmer et al.   NEW ENGLAND JOURNAL OF MEDICINE

Safety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer

(2012) Suzanne L. Topalian et al.   NEW ENGLAND JOURNAL OF MEDICINE

Normalized Median Fluorescence: An Alternative Flow Cytometry Analysis Method for Tracking Human Embryonic Stem Cell States During Differentiation

(2012) Lesley Y. Chan et al.   TISSUE ENGINEERING PART C-METHODS

A glycoengineered anti-CD19 antibody with potent antibody-dependent cellular cytotoxicity activity in vitro and lymphoma growth inhibition in vivo

(2011) Elizabeth Ward et al.   BRITISH JOURNAL OF HAEMATOLOGY

Mechanistic Modeling of Antigen Sink Effect for Mavrilimumab Following Intravenous Administration in Patients With Rheumatoid Arthritis

(2011) Bing Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

PK–PD modeling of protein drugs: implications in assay development

(2011) Lorin K Roskos et al.   Bioanalysis

Variables affecting the quantitation of CD22 in neoplastic B cells

(2010) Gregory A. Jasper et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

Phase I Study of Single-Agent Anti–Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates

(2010) Julie R. Brahmer et al.   JOURNAL OF CLINICAL ONCOLOGY

Recommendations for the validation of flow cytometric testing during drug development: I instrumentation

(2010) Cherie L. Green et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Recommendations for the validation of flow cytometric testing during drug development: II assays

(2010) Denise M. O'Hara et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Stability of immunophenotypic markers in fixed peripheral blood for extended analysis using flow cytometry

(2010) Cuc Davis et al.   JOURNAL OF IMMUNOLOGICAL METHODS

A randomized, double-blind, placebo-controlled, phase I study of MEDI-545, an anti–interferon-alfa monoclonal antibody, in subjects with chronic psoriasis

(2010) Robert Bissonnette et al.   JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Biodistribution Mechanisms of Therapeutic Monoclonal Antibodies in Health and Disease

(2009) Mohammad Tabrizi et al.   AAPS Journal

Neutralization of interferon-α/β-inducible genes and downstream effect in a phase I trial of an anti-interferon-α monoclonal antibody in systemic lupus erythematosus

(2009) Yihong Yao et al.   ARTHRITIS AND RHEUMATISM

Dose-Dependent Increases in Circulating TGF-  and Other EGFR Ligands Act As Pharmacodynamic Markers for Optimal Biological Dosing of Cetuximab and Are Tumor Independent

(2009) A. J. Mutsaers et al.   CLINICAL CANCER RESEARCH

Safety Assessment and Dose Selection for First-in-Human Clinical Trials With Immunomodulatory Monoclonal Antibodies

(2009) PY Muller et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Phase I, Pharmacokinetic, and Pharmacodynamic Study of AMG 479, a Fully Human Monoclonal Antibody to Insulin-Like Growth Factor Receptor 1

(2009) Anthony W. Tolcher et al.   JOURNAL OF CLINICAL ONCOLOGY

Use of biofluorescence imaging to compare the distribution of certolizumab pegol, adalimumab, and infliximab in the inflamed paws of mice with collagen-induced arthritis

(2009) Roger Palframan et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Near-Infrared Fluorescence Labeled Anti-TAG-72 Monoclonal Antibodies for Tumor Imaging in Colorectal Cancer Xenograft Mice

(2009) Peng Zou et al.   MOLECULAR PHARMACEUTICS

Structural characterization of a human Fc fragment engineered for lack of effector functions

(2008) Vaheh Oganesyan et al.   ACTA CRYSTALLOGRAPHICA SECTION D-BIOLOGICAL CRYSTALLOGRAPHY

A Phase II Study of Plerixafor (AMD3100) plus G-CSF for Autologous Hematopoietic Progenitor Cell Mobilization in Patients with Hodgkin Lymphoma

(2008) Amanda Cashen et al.   BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION

Mechanisms and pathologic significances in increase in serum interleukin-6 (IL-6) and soluble IL-6 receptor after administration of an anti-IL-6 receptor antibody, tocilizumab, in patients with rheumatoid arthritis and Castleman disease

(2008) N. Nishimoto et al.   BLOOD

Population pharmacokinetic/ pharmacodynamic analysis of CCR5 receptor occupancy by maraviroc in healthy subjects and HIV-positive patients

(2008) Maria C. Rosario et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics

(2008) Balaji M. Agoram   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Phase I, Pharmacokinetic and Pharmacodynamic Study of the Anti–Insulinlike Growth Factor Type 1 Receptor Monoclonal Antibody CP-751,871 in Patients With Multiple Myeloma

(2008) Martha Q. Lacy et al.   JOURNAL OF CLINICAL ONCOLOGY