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 inClinical and translational science Vol. 11; no. 6; pp. 540 - 552
Main Authors Ovacik, Meric, Lin, Kedan
Format Journal Article
LanguageEnglish
Published United States John Wiley and Sons Inc 01.11.2018
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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.
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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Vicini P. (e_1_2_12_83_1) 2016
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Title Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development
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