Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development
Учебное пособие по фармакокинетике моноклональных антител и ее учету на ранних этапах разработки
2018-06-07
SCID: 54.1/bwr2brdu
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antibody PK/PDearly development PK studiesmonoclonal antibody pharmacokineticsnonclinical PK program
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Abstract (AI)
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.
Key Findings
1
It describes the types of PK studies that should be performed during early development of monoclonal antibodies.
2
It explains how antibody PK/PD data are applied to R&D decision-making during early development.
3
The paper outlines general considerations for designing a nonclinical PK program for monoclonal antibodies.
4
The tutorial summarizes fundamental pharmacokinetic (PK) characteristics of monoclonal antibodies relevant to drug development.
Research Object
Monoclonal antibodies in early drug development
Research Subject
Pharmacokinetics (PK) characteristics and their application/considerations for planning nonclinical PK programs and PK/PD-informed decision-making in early development
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Publication Date
2018-06-07
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