Statistical perspectives on the use of pharmacovigilance data and electronic health records to verify predicted chemical hazards of drugs from in-vitro toxicological data

The liver is considered as one of the organs that are highly susceptible to drug-induced toxicity, leading to a diverse set of responses such as acute liver injuries, black-box warnings, and possible market withdrawal of medications in spite of having first appeared non-toxic and effective in animal and clinical studies. Over the last few decades, […]

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Evidence Integration and value of information

Decision makers responsible for managing public and population health risks are increasingly faced with challenges in integrating information from multiple sources to support evidence-based risk decision making. To meet these challenges, a new framework for evidence integration will be developed to provide guidance on how best to synthesize information from all relevant sources to support […]

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An overview of the Statistical Methods used in Passive Pharmacovigilance

  After pharmaceutical products are released into the market, a number of statistical methods are used to monitor the adverse effects of these drugs. If a large enough number of incidences are reported to regulatory bodies, appropriate measures are taken. This research project is dealing with the statistical methods used to decide on how many reports is required before […]

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Human Health Risk Assessment of Manganese and Inorganic Manganese Compounds and the Application of Categorical Regression in the Quantitative Risk Assessment of Manganese

Risk Sciences International is currently completing a comprehensive risk assessment of the potential human health effects of manganese. This assessment involves a systematic review of the worlds’ literature on epidemiological and toxicological studies of manganese, following which an international expert panel has scored all of the adverse health outcomes identified through this review using a 12-point […]

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Statistical Perspectives on Drug Safety Screening using Spontaneous Reporting Data and Electronic Health Records

Screening spontaneous reporting (SR) or electronic health records (EHR) data sets for adverse drug reactions (ADRs) has become an important component of drug safety. Much methodological work has been historically done on SR data, however, novel approaches are continually being suggested which merit critical review. Thus, we will first investigate some of these approaches as […]

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