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Dashboard systems: Pharmacokinetic/pharmacodynamic mediated dose optimization for monoclonal antibodies
Author(s) -
Mould Diane R.,
Dubinsky Marla C.
Publication year - 2015
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.370
Subject(s) - medicine , dosing , pharmacodynamics , monoclonal antibody , dashboard , drug , pharmacokinetics , intensive care medicine , clinical practice , pharmacology , infliximab , antibody , immunology , computer science , physical therapy , data science , tumor necrosis factor alpha
Abstract Many marketed drugs exhibit high variability in exposure and response. While these drugs are efficacious in their approved indications, finding appropriate dose regimens for individual patients is not straightforward. Similar dose adjustment problems are also seen with drugs that have a complex relationship between exposure and response and/or a narrow therapeutic window. This is particularly true for monoclonal antibodies, where prolonged dosing at a sub‐therapeutic dose can also elicit anti‐drug antibodies which will further compromise safety and efficacy. Thus, finding appropriate doses quickly would represent a substantial improvement in healthcare. Dashboard systems, which are decision‐support tools, offer an improved, convenient means of tailoring treatment for individual patients. This article reviews the clinical need for this approach, particularly with monoclonal antibodies, the design, development, and testing of such systems, and the likely benefits of dashboard systems in clinical practice. We focus on infliximab for reference.