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Advancing the utilization of real‐world data and real‐world evidence in clinical pharmacology and translational research—Proceedings from the ASCPT 2023 preconference workshop

Clinical and translational science, 2024-04, Vol.17 (4), p.e13785-n/a

2024

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Real-World Evidence Application in Translational Medicine: Making Use of Prescription Claims to Inform Drug-Drug Interactions of a New Psoriasis Treatment

Journal of clinical pharmacology, 2024-08

2024

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Identification of a Safe and Tolerable Carbamazepine Dosing Paradigm that Facilitates Effective Evaluation of CYP3A4 Induction

Clinical pharmacology and therapeutics, 2024-10, Vol.116 (4), p.1034-1041

2024

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Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL‐17A (LY3509754): A Phase I Randomized Placebo‐Controlled Study

Clinical pharmacology and therapeutics, 2024-05, Vol.115 (5), p.1152-1161

2024

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Impact of COVID‐19 on the Conduct and Design of Clinical Trials: IQ Consortium Perspective

Clinical pharmacology and therapeutics, 2024-07, Vol.116 (1), p.26-29

2024

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Physiologically Based Modeling to Predict Monoclonal Antibody Pharmacokinetics in Humans from in vitro Physiochemical Properties

mAbs, 2022, Vol.14 (1), p.2056944

2022

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

mAbs, 2015-05, Vol.7 (3), p.483-493

2015

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Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective

Clinical pharmacology and therapeutics, 2023-10, Vol.114 (4), p.751-767

2023

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Reducing target binding affinity improves the therapeutic index of anti-MET antibody-drug conjugate in tumor bearing animals

PloS one, 2024-04, Vol.19 (4), p.e0293703-e0293703

2024

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Antibody Conjugates-Recent Advances and Future Innovations

Antibodies (Basel), 2020-01, Vol.9 (1), p.2

2020

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Identification of a Multi-Component Formulation for Intestinal Delivery of a GLP-1/Glucagon Co-agonist Peptide

Pharmaceutical research, 2022-10, Vol.39 (10), p.2555-2567

2022

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The interplay of non-specific binding, target-mediated clearance and FcRn interactions on the pharmacokinetics of humanized antibodies

mAbs, 2015-11, Vol.7 (6), p.1084-1093

2015

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Influence of physiochemical properties on the subcutaneous absorption and bioavailability of monoclonal antibodies

mAbs, 2020-01, Vol.12 (1), p.1770028

2020

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Aberrant bispecific antibody pharmacokinetics linked to liver sinusoidal endothelium clearance mechanism in cynomolgus monkeys

mAbs, 2016-07, Vol.8 (5), p.969-982

2016

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Pharmacokinetic Developability and Disposition Profiles of Bispecific Antibodies: A Case Study with Two Molecules

Antibodies (Basel), 2021-12, Vol.11 (1), p.2

2021

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Engineered FcRn Binding Fusion Peptides Significantly Enhance the Half‐Life of a Fab Domain in Cynomolgus Monkeys

Biotechnology journal, 2019-03, Vol.14 (3), p.e1800007-n/a

2019

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FcRn affinity-pharmacokinetic relationship of five human IgG4 antibodies engineered for improved in vitro FcRn binding properties in cynomolgus monkeys

Drug metabolism and disposition, 2012-08, Vol.40 (8), p.1545-1555

2012

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Neonatal Fc receptor mediates internalization of Fc in transfected human endothelial cells

Molecular biology of the cell, 2008-12, Vol.19 (12), p.5490-5505

2008

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Humanized IgG1 variants with differential binding properties to the neonatal Fc receptor: relationship to pharmacokinetics in mice and primates

Drug metabolism and disposition, 2007-01, Vol.35 (1), p.86

2007

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Mechanisms Influencing the Pharmacokinetics and Disposition of Monoclonal Antibodies and Peptides

Drug metabolism and disposition, 2019-10, Vol.47 (10), p.1100-1110

Datta-Mannan, Amita

2019

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Monoclonal Antibody-Directed Therapy

2022

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Influence of improved FcRn binding on the subcutaneous bioavailability of monoclonal antibodies in cynomolgus monkeys

mAbs, 2012-03, Vol.4 (2), p.267-273

2012

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Follistatin: a novel therapeutic for the improvement of muscle regeneration

The Journal of pharmacology and experimental therapeutics, 2014-05, Vol.349 (2), p.355-371

2014

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Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper

Drug metabolism and disposition, 2016-05, Vol.44 (5), p.617-623

2016

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Monoclonal Antibody Clearance

The Journal of biological chemistry, 2007-01, Vol.282 (3), p.1709-1717

2007

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Advancing the utilization of real‐world data and real‐world evidence in clinical pharmacology and translational research—Proceedings from the ASCPT 2023 preconference workshop

Real-World Evidence Application in Translational Medicine: Making Use of Prescription Claims to Inform Drug-Drug Interactions of a New Psoriasis Treatment

Identification of a Safe and Tolerable Carbamazepine Dosing Paradigm that Facilitates Effective Evaluation of CYP3A4 Induction

Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL‐17A (LY3509754): A Phase I Randomized Placebo‐Controlled Study

Impact of COVID‐19 on the Conduct and Design of Clinical Trials: IQ Consortium Perspective

Physiologically Based Modeling to Predict Monoclonal Antibody Pharmacokinetics in Humans from in vitro Physiochemical Properties

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

Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective

Reducing target binding affinity improves the therapeutic index of anti-MET antibody-drug conjugate in tumor bearing animals

Antibody Conjugates-Recent Advances and Future Innovations

Identification of a Multi-Component Formulation for Intestinal Delivery of a GLP-1/Glucagon Co-agonist Peptide

The interplay of non-specific binding, target-mediated clearance and FcRn interactions on the pharmacokinetics of humanized antibodies

Influence of physiochemical properties on the subcutaneous absorption and bioavailability of monoclonal antibodies

Aberrant bispecific antibody pharmacokinetics linked to liver sinusoidal endothelium clearance mechanism in cynomolgus monkeys

Pharmacokinetic Developability and Disposition Profiles of Bispecific Antibodies: A Case Study with Two Molecules

Engineered FcRn Binding Fusion Peptides Significantly Enhance the Half‐Life of a Fab Domain in Cynomolgus Monkeys

FcRn affinity-pharmacokinetic relationship of five human IgG4 antibodies engineered for improved in vitro FcRn binding properties in cynomolgus monkeys

Neonatal Fc receptor mediates internalization of Fc in transfected human endothelial cells

Humanized IgG1 variants with differential binding properties to the neonatal Fc receptor: relationship to pharmacokinetics in mice and primates

Mechanisms Influencing the Pharmacokinetics and Disposition of Monoclonal Antibodies and Peptides

Monoclonal Antibody-Directed Therapy

Influence of improved FcRn binding on the subcutaneous bioavailability of monoclonal antibodies in cynomolgus monkeys

Follistatin: a novel therapeutic for the improvement of muscle regeneration

Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper

Monoclonal Antibody Clearance

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