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Pharmacokinetics‐Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap

Clinical pharmacology and therapeutics, 2024-03, Vol.115 (3), p.404-407

2024

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Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products

Clinical pharmacology and therapeutics, 2023-04, Vol.113 (4), p.794-802

2023

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Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins

Clinical pharmacology and therapeutics, 2024-03, Vol.115 (3), p.440-451

2024

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Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

The AAPS journal, 2016-03, Vol.18 (2), p.395-403

2016

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Clinical pharmacology considerations for first-in-human clinical trials for enzyme replacement therapy

Journal of inherited metabolic disease, 2024-05, Vol.47 (5), p.1096-1106

2024

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Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism

Clinical and translational science, 2023-12, Vol.16 (12), p.2438-2457

2023

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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Clinical pharmacology and therapeutics, 2020-01, Vol.107 (1), p.40-42

2020

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A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment

Pharmaceutical research, 2024, Vol.41 (1), p.13-27

2024

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Individualized Dosing of Therapeutic Monoclonal Antibodies—a Changing Treatment Paradigm?

The AAPS journal, 2018-09, Vol.20 (6), p.99-99, Article 99

2018

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Considerations for Biologic Product Drug–Drug Interactions: A Regulatory Perspective

Clinical pharmacology and therapeutics, 2019-06, Vol.105 (6), p.1332-1334

2019

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Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with lower risk myelodysplastic syndromes

Cancer, 2011-03, Vol.117 (5), p.992-1000

2011

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A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays

Pharmaceutical research, 2012-12, Vol.29 (12), p.3384-3392

2012

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Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure

Journal of clinical pharmacology, 2015-11, Vol.55 (11), p.1236-1247

2015

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Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Clinical and translational science, 2020-03, Vol.13 (2), p.219-223

2020

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Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development

Clinical pharmacology and therapeutics, 2023-01, Vol.113 (1), p.62-70

2023

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Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins

The AAPS journal, 2023-05, Vol.25 (4), p.54-54, Article 54

2023

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Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies

Trends in biotechnology (Regular ed.), 2010-10, Vol.28 (10), p.509-516

2010

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A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects

Bioanalysis, 2021-09, Vol.13 (17), p.1323-1332

2021

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Biological Products for the Treatment of Psoriasis: Therapeutic Targets, Pharmacodynamics and Disease-Drug-Drug Interaction Implications

The AAPS journal, 2014-09, Vol.16 (5), p.938-947

2014

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Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis

Bioanalysis, 2014-01, Vol.6 (1), p.79-87

2014

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Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

Biomarkers in medicine, 2019-07, Vol.13 (10), p.805-809

2019

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Investigation of the Pharmacokinetics of Romiplostim in Rodents with a Focus on the Clearance Mechanism

Pharmaceutical research, 2011-08, Vol.28 (8), p.1931-1938

2011

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Pharmacodynamics-Mediated Drug Disposition (PDMDD) and Precursor Pool Lifespan Model for Single Dose of Romiplostim in Healthy Subjects

The AAPS journal, 2010-12, Vol.12 (4), p.729-740

2010

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Romiplostim dose–response in patients with myelodysplastic syndromes

British journal of clinical pharmacology, 2013-06, Vol.75 (6), p.1445-1454

2013

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Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium

The AAPS journal, 2014-05, Vol.16 (3), p.586-591

2014

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Pharmacokinetics‐Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap

Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products

Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

Clinical pharmacology considerations for first-in-human clinical trials for enzyme replacement therapy

Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment

Individualized Dosing of Therapeutic Monoclonal Antibodies—a Changing Treatment Paradigm?

Considerations for Biologic Product Drug–Drug Interactions: A Regulatory Perspective

Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with lower risk myelodysplastic syndromes

A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays

Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development

Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins

Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies

A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects

Biological Products for the Treatment of Psoriasis: Therapeutic Targets, Pharmacodynamics and Disease-Drug-Drug Interaction Implications

Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis

Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

Investigation of the Pharmacokinetics of Romiplostim in Rodents with a Focus on the Clearance Mechanism

Pharmacodynamics-Mediated Drug Disposition (PDMDD) and Precursor Pool Lifespan Model for Single Dose of Romiplostim in Healthy Subjects

Romiplostim dose–response in patients with myelodysplastic syndromes

Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium

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