6 research outputs found

    Methodological and technological advances in safety pharmacology - New or simply nuanced?

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    This editorial previews and summarizes the content of the current themed issue of J Pharm Tox Methods derived from the recent 2018 Annual Safety Pharmacology Society (SPS) meeting held in Washington, DC. The papers highlight improvements in methods and study endpoints used in non-clinical safety pharmacology (SP) to enhance clinical translatability. Articles cover areas including the SP assessment of oligonucleotides and gene therapy, core battery clinical translation case studies, next generation non-opiate pain management strategy, aspects of cardio-oncology that extend the traditional objectives of an SP assessment, real-world advanced imaging techniques used in preclinical safety, in silico approaches including mathematical modeling, machine learning, and bioinformatics and how secondary SP studies impact clinical trial interpretation and design. The meeting included scientific content from > 190 abstracts (reproduced in the current volume of J Pharm Tox Methods).Stem cells & developmental biolog

    An overview of the safety pharmacology society strategic plan

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    Safety Pharmacology studies are conducted to characterize the confidence by which biologically active new chemical entities (NCE) may be anticipated as safe. Non-clinical safety pharmacology studies aim to detect and characterize potentially undesirable pharmacodynamic activities using an array of in silico, in vitro and in vivo animal models. While a broad spectrum of methodological innovation and advancement of the science occurs within the Safety Pharmacology Society, the society also focuses on partnerships with health authorities and technology providers and facilitates interaction with organizations of common interest such as pharmacology, physiology, neuroscience, cardiology and toxicology. Education remains a primary emphasis for the society through content derived from regional and annual meetings, webinars and publication of its works it seeks to inform the general scientific and regulatory community. In considering the future of safety pharmacology the society has developed a strategy to successfully navigate forward and not be mired in stagnation of the discipline. Strategy can be defined in numerous ways but generally involves establishing and setting goals, determining what actions are needed to achieve those goals, and mobilizing resources within the society to accomplish the actions. The discipline remains in rapid evolution and its coverage is certain to expand to provide better guidance for more systems in the next few years. This overview from the Safety Pharmacology Society will outline the strategic plan from 2016 to 2018 and beyond and provide insight into the future of the discipline which builds upon a previous strategic plan established in 2009

    Human Heart Cardiomyocytes in Drug Discovery and Research: New Opportunities in Translational Sciences

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