Pharmacokinetics and Pharmacodynamics: Advances in Modeling and Simulation of Biologics
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- Category: Vol. 80, December 2012
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Pharmacokinetics and Pharmacodynamics: Advances in Modeling and Simulation of Biologics
Abstract
Aim: This paper explores the evolution of biologic drug development, emphasizing the role of pharmacokinetics and pharmacodynamics modeling and simulation (PK/PD M&S) in optimizing the drug discovery process for therapeutic biolog-ics, particularly monoclonal antibodies (mAbs). Methods: A comprehensive literature review was conduct-ed, analyzing advancements in PK/PD modeling techniques and their application throughout various stages of drug devel-opment. The study also examined elimination pathways, bio-availability, and pharmacokinetic parameters specific to mAbs. Results: The integration of PK/PD M&S has significantly enhanced the ability to predict clinical outcomes, improve dos-ing strategies, and reduce costs associated with late-stage clini-cal trial failures. Insights gained from mAb pharmacokinetics highlight the importance of receptor-mediated and target-medi-ated clearance mechanisms, which influence drug efficacy and safety profiles. The findings indicate that early-stage applica-tion of PK/PD modeling facilitates the prioritization of promis-ing drug candidates. Conclusion: The ongoing evolution of biologic therapies, coupled with advanced modeling methodologies, holds great promise for transforming drug development. By addressing the challenges posed by increasing regulatory scrutiny and compet-itive pressures from biosimilars, PK/PD M&S serves as a vital tool in the quest for effective, safe, and innovative therapeutic options in the biopharmaceutical landscape.