Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development?

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

(2011) Jean W. Lee et al.   AAPS Journal

Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis

(2011) A.A. Fasanmade et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4

(2011) Daniela Bumbaca et al.   mAbs

Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data

(2011) Rong Deng et al.   mAbs

Complex Pharmacokinetics of a Humanized Antibody Against Human Amyloid Beta Peptide, Anti-Abeta Ab2, in Nonclinical Species

(2011) Yulia Vugmeyster et al.   PHARMACEUTICAL RESEARCH

Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases

(2011) Emilie Ducourau et al.   ARTHRITIS RESEARCH & THERAPY

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

(2010) C. Andrew Boswell et al.   BIOCONJUGATE CHEMISTRY

A Therapeutic Anti-VEGF Antibody with Increased Potency Independent of Pharmacokinetic Half-life

(2010) Y. A. Yeung et al.   CANCER RESEARCH

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Nathanael L. Dirks et al.   CLINICAL PHARMACOKINETICS

Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Ron J. Keizer et al.   CLINICAL PHARMACOKINETICS

Pharmacokinetic and Pharmacodynamic Perspectives on the Clinical Drug Development of Panitumumab

(2010) Bing-Bing Yang et al.   CLINICAL PHARMACOKINETICS

Pharmacokinetics of Humanized Monoclonal Anti-Tumor Necrosis Factor-  Antibody and Its Neonatal Fc Receptor Variants in Mice and Cynomolgus Monkeys

(2010) R. Deng et al.   DRUG METABOLISM AND DISPOSITION

A novel method for quantitative measurement of a therapeutic monoclonal antibody in the presence of its target protein using enzymatic digestion

(2010) Julie Doucet et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Target-mediated drug disposition model for drugs that bind to more than one target

(2010) Leonid Gibiansky et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

The Fate and Function of Therapeutic Antiaddiction Monoclonal Antibodies across the Reproductive Cycle of Rats

(2010) J. J. Hubbard et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

In vitro potency, pharmacokinetic profiles and pharmacological activity of optimized anti-IL-21R antibodies in a mouse model of lupus

(2010) Yulia Vugmeyster et al.   mAbs

Charge variants in IgG1

(2010) Leslie A. Khawli et al.   mAbs

Roche plans for more convenient-to-use Herceptin and Rituxan

(2010) Mark Ratner   NATURE BIOTECHNOLOGY

Oncogenic mutations as predictive factors in colorectal cancer

(2010) A Lièvre et al.   ONCOGENE

Interspecies Scaling of Receptor-Mediated Pharmacokinetics and Pharmacodynamics of Type I Interferons

(2010) Leonid Kagan et al.   PHARMACEUTICAL RESEARCH

Reduced elimination of IgG antibodies by engineering the variable region

(2010) T. Igawa et al.   PROTEIN ENGINEERING DESIGN & SELECTION

An Enzyme-Linked Immunosorbent Assay to Study Bevacizumab Pharmacokinetics

(2010) David Ternant et al.   THERAPEUTIC DRUG MONITORING

Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies

(2010) Wendy S. Putnam et al.   TRENDS IN BIOTECHNOLOGY

Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies

(2010) Eric Ezan et al.   Bioanalysis

Therapeutic monoclonal antibody concentration monitoring: free or total?

(2010) Bing Kuang et al.   Bioanalysis

Mechanism-based receptor-binding model to describe the pharmacokinetic and pharmacodynamic of an anti-α5β1 integrin monoclonal antibody (volociximab) in cancer patients

(2009) Chee M. Ng et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Scaling Pharmacodynamics from In Vitro and Preclinical Animal Studies to Humans

(2009) Donald E. Mager et al.   Drug Metabolism and Pharmacokinetics

Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis

(2009) Adedigbo A. Fasanmade et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Phase I and Pharmacokinetic Study of Cetuximab and Irinotecan in Children With Refractory Solid Tumors: A Study of the Pediatric Oncology Experimental Therapeutic Investigators' Consortium

(2009) Tanya M. Trippett et al.   JOURNAL OF CLINICAL ONCOLOGY

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

(2009) Jie Ling et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Engineering Human IgG1 Affinity to Human Neonatal Fc Receptor: Impact of Affinity Improvement on Pharmacokinetics in Primates

(2009) Y. A. Yeung et al.   JOURNAL OF IMMUNOLOGY

An Enzyme-Linked Immunosorbent Assay for Therapeutic Drug Monitoring of Cetuximab

(2009) Nicolas Cézé et al.   THERAPEUTIC DRUG MONITORING

Antibody tumor penetration: Transport opposed by systemic and antigen-mediated clearance

(2008) Greg M. Thurber et al.   ADVANCED DRUG DELIVERY REVIEWS

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

Clinical pharmacokinetics of bevacizumab in patients with solid tumors

(2008) Jian-Feng Lu et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Monoclonal Antibody Pharmacokinetics and Pharmacodynamics

(2008) W Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Phase I Trial and Pharmacokinetic Study of Bevacizumab in Pediatric Patients With Refractory Solid Tumors: A Children's Oncology Group Study

(2008) Julia L. Glade Bender et al.   JOURNAL OF CLINICAL ONCOLOGY

Population Pharmacokinetics of Infliximab in Patients With Ankylosing Spondylitis

(2008) Zhenhua Xu et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Integrated Cellular Bone Homeostasis Model for Denosumab Pharmacodynamics in Multiple Myeloma Patients

(2008) A. Marathe et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS