Predicting monoclonal antibody pharmacokinetics following subcutaneous administration via whole-body physiologically-based modeling

Subcutaneous delivery of biotherapeutics: challenges at the injection site

(2019) Joana A. D. Sequeira et al.   Expert Opinion on Drug Delivery

Five computational developability guidelines for therapeutic antibody profiling

(2019) Matthew I. J. Raybould et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Mechanisms Influencing The Disposition Of Monoclonal Antibodies And Peptides

(2019) Amita Datta-Mannan   DRUG METABOLISM AND DISPOSITION

Two-pore physiologically based pharmacokinetic model with de novo derived parameters for predicting plasma PK of different size protein therapeutics

(2019) Zhe Li et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Pharmacokinetics of Risankizumab in Asian Healthy Subjects and Patients With Moderate to Severe Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis

(2019) Amit Khatri et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Lymphatic System Flows

(2018) James E. Moore et al.   Annual Review of Fluid Mechanics

Understanding the Monoclonal Antibody Disposition after Subcutaneous Administration using a Minimal Physiologically based Pharmacokinetic Model

(2018) Ninad Varkhede et al.   JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities

(2018) Beate Bittner et al.   BIODRUGS

Subcutaneous delivery of monoclonal antibodies: How do we get there?

(2018) Margarida Viola et al.   JOURNAL OF CONTROLLED RELEASE

Physiologically-based modeling of monoclonal antibody pharmacokinetics in drug discovery and development

(2018) Patrick M. Glassman et al.   Drug Metabolism and Pharmacokinetics

Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Predicting the Effects of Anti-FcRn Therapy on the Disposition of Endogenous IgG in Humans

(2018) Tommy Li et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Distribution of FcRn Across Species and Tissues

(2017) Sari Latvala et al.   JOURNAL OF HISTOCHEMISTRY & CYTOCHEMISTRY

Physiologically Based Pharmacokinetic Modeling of Therapeutic Proteins

(2017) Harvey Wong et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Changes in complementarity-determining regions significantly alter IgG binding to the neonatal Fc receptor (FcRn) and pharmacokinetics

(2017) Nicole M. Piche-Nicholas et al.   mAbs

Monoclonal antibodies: A review of therapeutic applications and future prospects

(2017) Aliyu Mahmuda et al.   TROPICAL JOURNAL OF PHARMACEUTICAL RESEARCH

IPC – Isoelectric Point Calculator

(2016) Lukasz P. Kozlowski   Biology Direct

Physiologically based pharmacokinetic models of small molecules and therapeutic antibodies: a mini-review on fundamental concepts and applications

(2016) Gregory Z. Ferl et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis

(2016) Yanli Zhuang et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Physiologically-based pharmacokinetic modeling to predict the clinical pharmacokinetics of monoclonal antibodies

(2016) Patrick M. Glassman et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Are Physiologically Based Pharmacokinetic Models Reporting the Right Cmax? Central Venous Versus Peripheral Sampling Site

(2015) Helen Musther et al.   AAPS Journal

A Bottom-Up Whole-Body Physiologically Based Pharmacokinetic Model to Mechanistically Predict Tissue Distribution and the Rate of Subcutaneous Absorption of Therapeutic Proteins

(2015) Katherine L. Gill et al.   AAPS Journal

Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial

(2015) Jun Morita et al.   BIODRUGS

Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study

(2015) Won Park et al.   Expert Review of Clinical Immunology

Evaluating the Use of Antibody Variable Region (Fv) Charge as a Risk Assessment Tool for Predicting Typical Cynomolgus Monkey Pharmacokinetics

(2015) Daniela Bumbaca Yadav et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients — A twelve month follow-up

(2015) Tobias Derfuss et al.   JOURNAL OF NEUROIMMUNOLOGY

Development of a physiologically based pharmacokinetic model for a domain antibody in mice using the two-pore theory

(2015) Armin Sepp et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Key factors influencing ADME properties of therapeutic proteins: A need for ADME characterization in drug discovery and development

(2015) Jay Tibbitts et al.   mAbs

Balancing charge in the complementarity-determining regions of humanized mAbs without affecting pI reduces non-specific binding and improves the pharmacokinetics

(2015) Amita Datta-Mannan et al.   mAbs

Charge-mediated influence of the antibody variable domain on FcRn-dependent pharmacokinetics

(2015) Angela Schoch et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

The endosomal-lysosomal system: from acidification and cargo sorting to neurodegeneration

(2015) Yong-Bo Hu et al.   Translational Neurodegeneration

Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers: Integrated Analysis of Intravenous and Subcutaneous, Single- and Multiple-Dose Administration

(2014) Ahmed A. Othman et al.   CLINICAL PHARMACOKINETICS

Improving the outcomes of biopharmaceutical delivery via the subcutaneous route by understanding the chemical, physical and physiological properties of the subcutaneous injection site

(2014) Hanne M. Kinnunen et al.   JOURNAL OF CONTROLLED RELEASE

Framework selection can influence pharmacokinetics of a humanized therapeutic antibody through differences in molecule charge

(2014) Bing Li et al.   mAbs

In silico selection of therapeutic antibodies for development: Viscosity, clearance, and chemical stability

(2014) Vikas K. Sharma et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase

(2013) O Shpilberg et al.   BRITISH JOURNAL OF CANCER

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

Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration

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

Pharmacokinetic and Pharmacodynamic Properties of Canakinumab, a Human Anti-Interleukin-1β Monoclonal Antibody

(2012) Abhijit Chakraborty et al.   CLINICAL PHARMACOKINETICS

Effects of Gevokizumab on Glycemia and Inflammatory Markers in Type 2 Diabetes

(2012) C. Cavelti-Weder et al.   DIABETES CARE

Pharmacokinetics and Pharmacodynamics of Figitumumab, a Monoclonal Antibody Targeting the Insulin-Like Growth Factor 1 Receptor, in Healthy Participants

(2012) Donghua Yin et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Modelling the lymphatic system: challenges and opportunities

(2012) K. N. Margaris et al.   Journal of the Royal Society Interface

Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration

(2012) Yanan Zheng et al.   mAbs

A strategy for risk mitigation of antibodies with fast clearance

(2012) Isidro Hötzel et al.   mAbs

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

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

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

An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males

(2010) Chad K. Oh et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetic and Pharmacodynamic Modeling of an Anti-Interleukin-6 Chimeric Monoclonal Antibody (Siltuximab) in Patients with Metastatic Renal Cell Carcinoma

(2010) T. Puchalski et al.   CLINICAL CANCER RESEARCH

Charge variants in IgG1

(2010) Leslie A. Khawli et al.   mAbs

Reduced elimination of IgG antibodies by engineering the variable region

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

Safety and Pharmacokinetics of Urtoxazumab, a Humanized Monoclonal Antibody, against Shiga-Like Toxin 2 in Healthy Adults and in Pediatric Patients Infected with Shiga-Like Toxin-Producing Escherichia coli

(2009) E. L. Lopez et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Proteolysis: A Biological Process Adapted in Drug Delivery, Therapy, and Imaging

(2009) Benedict Law et al.   BIOCONJUGATE CHEMISTRY

Three-dimensional ultrasound measurement of cervical lymph node volume

(2009) M YING et al.   BRITISH JOURNAL OF RADIOLOGY

Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers

(2009) Barbara White et al.   CLINICAL THERAPEUTICS

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

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

The INFUSE-Morphine IIB Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneous Morphine in Healthy Volunteers

(2009) Jay R. Thomas et al.   JOURNAL OF PAIN AND SYMPTOM MANAGEMENT

Open-label, dose escalation phase I study in healthy volunteers to evaluate the safety and pharmacokinetics of a human monoclonal antibody to Clostridium difficile toxin A

(2008) Claribel P. Taylor et al.   VACCINE