Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Evaluation of disease-mediated therapeutic protein-drug interactions between an anti-interleukin-6 monoclonal antibody (sirukumab) and cytochrome P450 activities in a phase 1 study in patients with rheumatoid arthritis using a cocktail approach

(2015) Yanli Zhuang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Simplification of Complex Physiologically Based Pharmacokinetic Models of Monoclonal Antibodies

(2014) Mohamed Elmeliegy et al.   AAPS Journal

Simulation of Monoclonal Antibody Pharmacokinetics in HumansUsing a Minimal Physiologically Based Model

(2014) Linzhong Li et al.   AAPS Journal

Lower etanercept levels are associated with high disease activity in ankylosing spondylitis patients at 24 weeks of follow-up

(2014) E L Kneepkens et al.   ANNALS OF THE RHEUMATIC DISEASES

Pharmacokinetics and Pharmacokinetic–Pharmacodynamic Relationships of Monoclonal Antibodies in Children

(2014) Helena Edlund et al.   CLINICAL PHARMACOKINETICS

Assessment of the Influence of Inflammation and FCGR3A Genotype on Infliximab Pharmacokinetics and Time to Relapse in Patients with Crohn’s Disease

(2014) David Ternant et al.   CLINICAL PHARMACOKINETICS

The Modulating Effects of Endogenous Substances on Drug Metabolising Enzymes and Implications for Inter-Individual Variability and Quantitative Prediction

(2014) Younus Azam et al.   CURRENT DRUG METABOLISM

Polymorphisms of Neonatal Fc Receptor in Cynomolgus and Rhesus Macaques

(2014) Yasuhiro Uno et al.   Drug Metabolism and Pharmacokinetics

Monoclonal antibody disposition: a simplified PBPK model and its implications for the derivation and interpretation of classical compartment models

(2014) Ludivine Fronton et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Pharmacokinetic study and Fcγ receptor gene analysis in two patients with rheumatoid arthritis controlled by low-dose infliximab

(2014) Shinichiro Nishio et al.   Modern Rheumatology

Interspecies Pharmacokinetic Modeling of Subcutaneous Absorption of Rituximab in Mice and Rats

(2014) Leonid Kagan et al.   PHARMACEUTICAL RESEARCH

Ontogeny of early life immunity

(2014) David J. Dowling et al.   TRENDS IN IMMUNOLOGY

Evaluation of Pre-existing Antibody Presence as a Risk Factor for Posttreatment Anti-drug Antibody Induction: Analysis of Human Clinical Study Data for Multiple Biotherapeutics

(2013) Li Xue et al.   AAPS Journal

A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics

(2013) Xiaoying Chen et al.   AAPS Journal

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

(2013) Jane R. Kenny et al.   AAPS Journal

Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis

(2013) David Ternant et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Soluble human epidermal growth factor receptor 2 (HER2) levels in patients with HER2-positive breast cancer receiving chemotherapy with or without trastuzumab: Results from North Central Cancer Treatment Group adjuvant trial N9831

(2013) Alvaro Moreno-Aspitia et al.   CANCER

Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Belatacept in Adult Kidney Transplant Recipients

(2013) Jinshan Shen et al.   CLINICAL DRUG INVESTIGATION

Pharmacokinetics, Pharmacodynamics and Physiologically-Based Pharmacokinetic Modelling of Monoclonal Antibodies

(2013) Miroslav Dostalek et al.   CLINICAL PHARMACOKINETICS

A Physiologically Based Pharmacokinetic Modeling Approach to Predict Disease–Drug Interactions: Suppression of CYP3A by IL-6

(2013) K K Machavaram et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Antibody Drug Absorption Following Subcutaneous or Intramuscular Administration and Its Mathematical Description by Coupling Physiologically Based Absorption Process with the Conventional Compartment Pharmacokinetic Model

(2013) Liang Zhao et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Contribution of Renal and Non-Renal Clearance on Increased Total Clearance of Adalimumab in Glomerular Disease

(2013) Brittney V. Roberts et al.   JOURNAL OF CLINICAL PHARMACOLOGY

A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?

(2013) Koji Chiba et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Immunogenicity of therapeutic proteins: Influence of aggregation

(2013) Kirsty D. Ratanji et al.   Journal of Immunotoxicology

Second-generation minimal physiologically-based pharmacokinetic model for monoclonal antibodies

(2013) Yanguang Cao et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Are endosomal trafficking parameters better targets for improving mAb pharmacokinetics than FcRn binding affinity?

(2013) Brian Gurbaxani et al.   MOLECULAR IMMUNOLOGY

Human and Non-Human Primate Intestinal FcRn Expression and Immunoglobulin G Transcytosis

(2013) Pamela J. Hornby et al.   PHARMACEUTICAL RESEARCH

Clinical Feasibility of Noninvasive Visualization of Lymphatic Flow with Principles of Spin Labeling MR Imaging: Implications for Lymphedema Assessment

(2013) Swati Rane et al.   RADIOLOGY

The Role of Fcγ Receptor Polymorphisms in the Response to Anti–Tumor Necrosis Factor Therapy in Psoriasis

(2013) Marc Julià et al.   JAMA Dermatology

Absorption, Distribution, Metabolism, and Excretion (ADME) Studies of Biotherapeutics for Autoimmune and Inflammatory Conditions

(2012) Yulia Vugmeyster et al.   AAPS Journal

The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics

(2012) Juan Jose Perez Ruixo et al.   AAPS Journal

Pharmacokinetic mAb–mAb Interaction: Anti-VEGF mAb Decreases the Distribution of Anti-CEA mAb into Colorectal Tumor Xenografts

(2012) Lubna Abuqayyas et al.   AAPS Journal

Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics

(2012) Lei Zhou et al.   AAPS Journal

Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy

(2012) Narendra Chirmule et al.   AAPS Journal

Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration

(2012) Wolfgang F. Richter et al.   AAPS Journal

Evaluation of a Catenary PBPK Model for Predicting the In Vivo Disposition of mAbs Engineered for High-Affinity Binding to FcRn

(2012) Yang Chen et al.   AAPS Journal

Contribution of FcRn binding to intestinal uptake of IgG in suckling rat pups and human FcRn-transgenic mice

(2012) C. Kliwinski et al.   AMERICAN JOURNAL OF PHYSIOLOGY-GASTROINTESTINAL AND LIVER PHYSIOLOGY

Population Pharmacokinetics of Palivizumab, a Humanized Anti-Respiratory Syncytial Virus Monoclonal Antibody, in Adults and Children

(2012) Gabriel J. Robbie et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Low infliximab serum trough levels and anti-infliximab antibodies are prevalent in rheumatoid arthritis patients treated with infliximab in daily clinical practice: results of an observational cohort study

(2012) Aatke van der Maas et al.   BMC MUSCULOSKELETAL DISORDERS

Up Regulated Complement and Fc Receptors in Juvenile Idiopathic Arthritis and Correlation with Disease Phenotype

(2012) Kajsa E. Prokopec et al.   JOURNAL OF CLINICAL IMMUNOLOGY

Characterizing the Impact of Renal Impairment on the Clinical Pharmacology of Biologics

(2012) Bernd Meibohm et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Applications of minimal physiologically-based pharmacokinetic models

(2012) Yanguang Cao et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Rational development and utilization of antibody-based therapeutic proteins in pediatrics

(2012) Zhenhua Xu et al.   PHARMACOLOGY & THERAPEUTICS

AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development

(2011) Sandhya Girish et al.   AAPS Journal

Baseline tumour necrosis factor alpha levels predict the necessity for dose escalation of infliximab therapy in patients with rheumatoid arthritis

(2011) T. Takeuchi et al.   ANNALS OF THE RHEUMATIC DISEASES

A Single-Species Approach Considering Additional Physiological Information for Prediction of Hepatic Clearance of Glycoprotein Derivate Therapeutics

(2011) Patrick Poulin   CLINICAL PHARMACOKINETICS

Disease–Drug–Drug Interaction Involving Tocilizumab and Simvastatin in Patients With Rheumatoid Arthritis

(2011) C Schmitt et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

How Current Understanding of Clearance Mechanisms and Pharmacodynamics of Therapeutic Proteins Can Be Applied for Evaluation of Their Drug-Drug Interaction Potential

(2011) E. Kraynov et al.   DRUG METABOLISM AND DISPOSITION

Population pharmacokinetics of golimumab in patients with ankylosing spondylitis: impact of body weight and immunogenicity

(2011) Z.H. Xu et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human

(2011) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Subcutaneous Absorption of Monoclonal Antibodies: Role of Dose, Site of Injection, and Injection Volume on Rituximab Pharmacokinetics in Rats

(2011) Leonid Kagan et al.   PHARMACEUTICAL RESEARCH

Gatabolism and Distribution of Gammaglobulin A Preliminary Study with 131I-labelled Gammaglobulin

(2010) G. Birke et al.   ACTA MEDICA SCANDINAVICA

Extent and Clinical Consequences of Antibody Formation Against Adalimumab in Patients With Plaque Psoriasis

(2010) Lidian L. A. Lecluse et al.   ARCHIVES OF DERMATOLOGY

Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies

(2010) Diane R. Mould et al.   BIODRUGS

Down regulation of Fc and complement receptors on B cells in rheumatoid arthritis

(2010) Kajsa E. Prokopec et al.   CLINICAL IMMUNOLOGY

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

Genetic Polymorphisme of FCGRT Encoding FcRn in a Japanese Population and Their Functional Analysis

(2010) Akiko Ishii-Watabe et al.   Drug Metabolism and Pharmacokinetics

Access to the Spleen Microenvironment through Lymph Shows Local Cytokine Production, Increased Cell Flux, and Altered Signaling of Immune Cells during Lipopolysaccharide-Induced Acute Inflammation

(2010) E. Semaeva et al.   JOURNAL OF IMMUNOLOGY

Therapeutic monoclonal antibody concentration monitoring: free or total?

(2010) Bing Kuang et al.   Bioanalysis

Biodistribution Mechanisms of Therapeutic Monoclonal Antibodies in Health and Disease

(2009) Mohammad Tabrizi et al.   AAPS Journal

Age-Related Lymphatic Dysfunction in Melanoma Patients

(2009) W. Charles Conway et al.   ANNALS OF SURGICAL ONCOLOGY

Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study

(2009) G. M. Bartelds et al.   ANNALS OF THE RHEUMATIC DISEASES

Development of a PBPK Model for Monoclonal Antibodies and Simulation of Human and Mice PBPK of a Radiolabelled Monoclonal Antibody

(2009) Tomi Heiskanen et al.   CURRENT PHARMACEUTICAL DESIGN

Risk-based strategy for the assessment of pharmacokinetic drug–drug interactions for therapeutic monoclonal antibodies

(2009) Honghui Zhou et al.   DRUG DISCOVERY TODAY

The Versatile MHC Class I-related FcRn Protects IgG and Albumin from Degradation: Implications for Development of New Diagnostics and Therapeutics

(2009) Jan Terje Andersen et al.   Drug Metabolism and Pharmacokinetics

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

(2009) Masoud Jamei 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

The Simcyp®Population-based ADME Simulator

(2009) Masoud Jamei et al.   Expert Opinion on Drug Metabolism & Toxicology

Utility of Serum HER2 Extracellular Domain Assessment in Clinical Decision Making: Pooled Analysis of Four Trials of Trastuzumab in Metastatic Breast Cancer

(2009) Siân Lennon et al.   JOURNAL OF CLINICAL ONCOLOGY

Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials

(2009) Diane D. Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Population Pharmacokinetic Analysis of Panitumumab in Patients With Advanced Solid Tumors

(2009) Peiming Ma et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Population Pharmacokinetic Modeling of Ustekinumab, a Human Monoclonal Antibody Targeting IL-12/23p40, in Patients With Moderate to Severe Plaque Psoriasis

(2009) Yaowei Zhu et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Subcutaneous Bioavailability of Golimumab at 3 Different Injection Sites in Healthy Subjects

(2009) Zhenhua Xu et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody

(2009) Shweta R. Urva et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2009) Nicolas Cézé et al.   THERAPEUTIC DRUG MONITORING

Population pharmacokinetic data analysis of three phase I studies of matuzumab, a humanised anti-EGFR monoclonal antibody in clinical cancer development

(2008) K Kuester et al.   BRITISH JOURNAL OF CANCER

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

Predictive Physiologically Based Pharmacokinetic Model for Antibody-Directed Enzyme Prodrug Therapy

(2008) L. Fang et al.   DRUG METABOLISM AND DISPOSITION

Population Pharmacokinetics of Cetuximab in Patients With Squamous Cell Carcinoma of the Head and Neck

(2008) Nathanae L. Dirks et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Population Pharmacokinetics of Infliximab in Patients With Ankylosing Spondylitis

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

A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs

(2007) Jasmine P. Davda et al.   INTERNATIONAL IMMUNOPHARMACOLOGY