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Subcutaneous absorption of biotherapeutics: knowns and unknowns

Drug metabolism and disposition, 2014-11, Vol.42 (11), p.1881-1889

2014

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Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration

The AAPS journal, 2012-09, Vol.14 (3), p.559-570

2012

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Heparin chromatography as an in vitro predictor for antibody clearance rate through pinocytosis

mAbs, 2020-01, Vol.12 (1), p.1683432

2020

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Effect of variable domain charge on in vitro and in vivo disposition of monoclonal antibodies

mAbs, 2021-01, Vol.13 (1), p.1993769-1993769

2021

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Are Biotransformation Studies of Therapeutic Proteins Needed? Scientific Considerations and Technical Challenges

Drug metabolism and disposition, 2019-12, Vol.47 (12), p.1443-1456

2019

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Protease-activation using anti-idiotypic masks enables tumor specificity of a folate receptor 1-T cell bispecific antibody

Nature communications, 2020-06, Vol.11 (1), p.3196-14, Article 3196

2020

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Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice

mAbs, 2018-07, Vol.10 (5), p.803-813

2018

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Non-human primates in the PKPD evaluation of biologics: Needs and options to reduce, refine, and replace. A BioSafe White Paper

mAbs, 2022-12, Vol.14 (1), p.2145997

2022

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Dynamic Contrast-Enhanced Magnetic Resonance Imaging for the Prediction of Monoclonal Antibody Tumor Disposition

International journal of molecular sciences, 2022-01, Vol.23 (2), p.679

2022

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Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys

PloS one, 2013-11, Vol.8 (11), p.e80533

2013

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Analysis of erlotinib and its metabolites in rat tissue sections by MALDI quadrupole time-of-flight mass spectrometry

Journal of mass spectrometry., 2007-07, Vol.42 (7), p.900-909

2007

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6‑Alkoxy-5-aryl-3-pyridinecarboxamides, a New Series of Bioavailable Cannabinoid Receptor Type 1 (CB1) Antagonists Including Peripherally Selective Compounds

Journal of medicinal chemistry, 2013-12, Vol.56 (24), p.9874-9896

2013

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Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting

mAbs, 2021-01, Vol.13 (1), p.1938796

2021

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Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies

AAPS open, 2022-02, Vol.8 (1), p.1-18, Article 3

2022

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Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab

Journal of pharmaceutical sciences, 2022-04, Vol.111 (4), p.1208-1218

2022

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Gantenerumab: a novel human anti-Aβ antibody demonstrates sustained cerebral amyloid-β binding and elicits cell-mediated removal of human amyloid-β

Journal of Alzheimer's disease, 2012-01, Vol.28 (1), p.49-69

2012

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Reproductive and developmental toxicology studies with gantenerumab in PS2APP transgenic mice

Reproductive toxicology (Elmsford, N.Y.), 2017-10, Vol.73, p.362-371

2017

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In Vivo Biotransformation of the Fusion Protein Tetranectin-Apolipoprotein A1 Analyzed by Ligand-Binding Mass Spectrometry Combined with Quantitation by ELISA

Analytical chemistry (Washington), 2016-12, Vol.88 (23), p.11670-11677

2016

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PKPD Assessment of the Anti-CD20 Antibody Obinutuzumab in Cynomolgus Monkey is Feasible Despite Marked Anti-Drug Antibody Response in This Species

Journal of pharmaceutical sciences, 2019-11, Vol.108 (11), p.3729-3736

2019

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Subcutaneous Site-of-Absorption Study with the Monoclonal Antibody Tocilizumab in Minipigs: Administration Behind Ear Translates Best to Humans

The AAPS journal, 2020-04, Vol.22 (3), p.63, Article 63

2020

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Nonclinical Development of Biologics: Integrating Safety, Pharmacokinetics, and Pharmacodynamics to Create Smarter and More Flexible Nonclinical Safety Programs Optimizing Animal Use

International journal of toxicology, 2021-05, Vol.40 (3), p.270-284

2021

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High-Throughput, Sensitive LC-MS Quantification of Biotherapeutics and Biomarkers Using Antibody-Free, Peptide-Level, Multiple-Mechanism Enrichment via Strategic Regulation of pH and Ionic and Solvent Strengths

Analytical chemistry (Washington), 2019-03, Vol.91 (5), p.3475-3483

2019

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The Effects of Interleukin-6 Signal Blockade on Immune System, Reproductive and Skeletal Development in Juvenile Mice

Birth defects research. Part B. Developmental and reproductive toxicology, 2013-04, Vol.98 (2), p.170-182

2013

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Neonatal Immune Tolerance Induction to Allow Long-Term Studies With an Immunogenic Therapeutic Monoclonal Antibody in Mice

The AAPS journal, 2016-03, Vol.18 (2), p.354-361

2016

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The distribution pattern of radioactivity across different tissues in quantitative whole-body autoradiography (QWBA) studies

European journal of pharmaceutical sciences, 2006-05, Vol.28 (1), p.155-165

2006

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Subcutaneous absorption of biotherapeutics: knowns and unknowns

Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration

Heparin chromatography as an in vitro predictor for antibody clearance rate through pinocytosis

Effect of variable domain charge on in vitro and in vivo disposition of monoclonal antibodies

Are Biotransformation Studies of Therapeutic Proteins Needed? Scientific Considerations and Technical Challenges

Protease-activation using anti-idiotypic masks enables tumor specificity of a folate receptor 1-T cell bispecific antibody

Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice

Non-human primates in the PKPD evaluation of biologics: Needs and options to reduce, refine, and replace. A BioSafe White Paper

Dynamic Contrast-Enhanced Magnetic Resonance Imaging for the Prediction of Monoclonal Antibody Tumor Disposition

Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys

Analysis of erlotinib and its metabolites in rat tissue sections by MALDI quadrupole time-of-flight mass spectrometry

6‑Alkoxy-5-aryl-3-pyridinecarboxamides, a New Series of Bioavailable Cannabinoid Receptor Type 1 (CB1) Antagonists Including Peripherally Selective Compounds

Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting

Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies

Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab

Gantenerumab: a novel human anti-Aβ antibody demonstrates sustained cerebral amyloid-β binding and elicits cell-mediated removal of human amyloid-β

Reproductive and developmental toxicology studies with gantenerumab in PS2APP transgenic mice

In Vivo Biotransformation of the Fusion Protein Tetranectin-Apolipoprotein A1 Analyzed by Ligand-Binding Mass Spectrometry Combined with Quantitation by ELISA

PKPD Assessment of the Anti-CD20 Antibody Obinutuzumab in Cynomolgus Monkey is Feasible Despite Marked Anti-Drug Antibody Response in This Species

Subcutaneous Site-of-Absorption Study with the Monoclonal Antibody Tocilizumab in Minipigs: Administration Behind Ear Translates Best to Humans

Nonclinical Development of Biologics: Integrating Safety, Pharmacokinetics, and Pharmacodynamics to Create Smarter and More Flexible Nonclinical Safety Programs Optimizing Animal Use

High-Throughput, Sensitive LC-MS Quantification of Biotherapeutics and Biomarkers Using Antibody-Free, Peptide-Level, Multiple-Mechanism Enrichment via Strategic Regulation of pH and Ionic and Solvent Strengths

The Effects of Interleukin-6 Signal Blockade on Immune System, Reproductive and Skeletal Development in Juvenile Mice

Neonatal Immune Tolerance Induction to Allow Long-Term Studies With an Immunogenic Therapeutic Monoclonal Antibody in Mice

The distribution pattern of radioactivity across different tissues in quantitative whole-body autoradiography (QWBA) studies

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