Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development
The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision‐...
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Published in | Clinical and translational science Vol. 11; no. 6; pp. 540 - 552 |
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Main Authors | , |
Format | Journal Article |
Language | English |
Published |
United States
John Wiley and Sons Inc
01.11.2018
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Subjects | |
Online Access | Get full text |
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Abstract | The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision‐making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early development of monoclonal antibodies. |
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AbstractList | The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision‐making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early development of monoclonal antibodies. The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision-making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early development of monoclonal antibodies.The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision-making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early development of monoclonal antibodies. |
Author | Ovacik, Meric Lin, Kedan |
AuthorAffiliation | 1 Department of Preclinical and Translational Pharmacokinetics Genentech, Inc. South San Francisco California USA 2 Clinical Pharmacology NGM Biopharmaceuticals, Inc. South San Francisco California USA |
AuthorAffiliation_xml | – name: 1 Department of Preclinical and Translational Pharmacokinetics Genentech, Inc. South San Francisco California USA – name: 2 Clinical Pharmacology NGM Biopharmaceuticals, Inc. South San Francisco California USA |
Author_xml | – sequence: 1 givenname: Meric surname: Ovacik fullname: Ovacik, Meric organization: Genentech, Inc – sequence: 2 givenname: Kedan surname: Lin fullname: Lin, Kedan email: kiln@ngmbio.com organization: NGM Biopharmaceuticals, Inc |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29877608$$D View this record in MEDLINE/PubMed |
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Copyright | 2018 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics 2018 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. |
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