The Certara Blog: PBPK Modeling & Simulation

Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and […]

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Predicting mAb Pharmacokinetics in Humans with a Minimal PBPK Model

Predicting mAb Pharmacokinetics in Humans with a Minimal PBPK Model

Monoclonal antibodies (mAbs) and their derivatives are a rapidly growing segment of the pharmaceutical industry’s pipeline. In fact, more than 40 mAbs and derivatives have been approved for a variety of therapeutic applications; around 500 mAbs and derivatives are currently in different stages of development. Monoclonal antibodies have pharmacokinetic (PK) properties that are quite distinct from that […]

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