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QSP can inform designing First-in-Human clinical trials to help determine the starting dose and subsequent dose escalations to ensure human subject safety.
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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 […]
Read MoreBiologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
Read MoreQuantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One factor critical to the ultimate success of QSP is the establishment of commonly accepted language, technical criteria, and workflows. We propose an integrated workflow that bridges conceptual objectives with underlying technical detail to support the execution, communication, and evaluation of […]
Read MoreQuantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.
Read MoreThe level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In 2011, PF-04457845, an irreversible inhibitor of FAAH, was progressed to phase II clinical trials for osteoarthritic pain. This article discusses a prospective, integrated systems pharmacology model evaluation of FAAH as a target for pain in humans, using physiologically based pharmacokinetic […]
Read MoreThe pharmaceutical industry continues to face significant challenges. Very few compounds that enter development reach the marketplace, and the investment required for each success can surpass $1.8 billion. Despite attempts to improve efficiency and increase productivity, total investment continues to rise whereas the output of new medicines declines. With costs increasing exponentially through each development […]
Read MoreThe nerve growth factor (NGF) pathway is of great interest as a potential source of drug targets, for example in the management of certain types of pain. However, selecting targets from this pathway either by intuition or by non-contextual measures is likely to be challenging. An alternative approach is to construct a mathematical model of […]
Read MoreSystems pharmacology is an emerging approach that sets out to use quantitative concepts rooted in the synergy between modeling and simulation on one hand and large-scale data collection and analysis on the other to investigate biological systems and design therapeutic interventions. Interest in this field has recently increased substantially, but so have perceived challenges and […]
Read MoreReviews of the productivity of the pharmaceutical industry have concluded that the current business model is unsustainable. Various remedies for this have been proposed, however, arguably these do not directly address the fundamental issue; namely, that it is the knowledge required to enable good decisions in the process of delivering a drug that is largely […]
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Mechanistic PKPD models are now advocated not only by academic and industrial researchers, but also by regulators. A recent development in this area is based on the growing realisation that innovation could be dramatically catalysed by creating synergy at the interface between Systems Biology and PKPD, two disciplines which until now have largely existed in […]
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