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Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies

Paper ID Volume ID Publish Year Pages File Format Full-Text
37385 45348 2010 8 PDF Available
Title
Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies
Abstract

Regulatory guidance stipulates that comparability assessment is required to support manufacturing process changes during the development of a biological product or post-approval. However, strategies for assessing the comparability of pre- and post-change materials are still evolving. A hierarchical risk-based approach is recommended, starting with analytical testing to ensure quality, followed by biological characterization and, if needed, in vivo pharmacokinetic (PK), PK–pharmacodynamic (PD), safety and/or efficacy studies. The need for an in vivo study and the type of study required depend on the magnitude and the potential impact of the changes and the timing in the development process. This review discusses factors affecting the PK, PD and immunogenicity of monoclonal antibodies, and provides guidance for determining non-clinical and clinical comparability assessment strategies.

First Page Preview
Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies
Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 28, Issue 10, October 2010, Pages 509–516
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering