Upcoming Webinars: May 2019

SOT Component Groups (Regional Chapters, Special Interest Groups, and Specialty Sections) and committees host webinars throughout the year. Webinars are an effective distance-learning method intended to impart scientific knowledge to members of their group as well as the SOT membership at large. These webinars are just one of the many benefits of SOT membership.

Upcoming webinars for May 2019 are listed below.

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Preclinical and Clinical Toxicology Consideration for Drugs of Abuse

Host: Mid-Atlantic Regional Chapter (MASOT)

Date and Time: Wednesday, May 8, 2019, 12:00 Noon–2:00 PM (EDT)

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The purpose of this webinar is to introduce the basic pharmacology and abuse-related toxicological effects of several drugs of abuse, most notably opioids and synthetic cannabinoids. Medical intervention practices and potential clinical outcomes resulting from intervention also will be discussed.

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Introduction and Use of the Open-Source PBPK Modeling R Package PLETHEM

Host: Biological Modeling Specialty Section (BMSS)

Date and Time: Monday, May 20, 2019, 1:00 PM–2:00 PM (EDT)

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This is new software available to the public. Population life course exposure to health effects model (PLETHEM) is a free, open-source platform that makes pharmacokinetic modeling approaches more accessible to chemical safety practitioners. PLETHEM provides a quantitative bridge between external chemical exposure and internal dose to better understand and evaluate potential health effects at realistic levels of exposure. PLETHEM is designed to make pharmacokinetic modeling more intuitive to practitioners by providing a menu-driven interface and workflows for common tasks such as IVIVE, PBPK modeling, HT-IVIVE, and importing exposure estimates. The webinar will feature instructions on installing PLETHEM, a brief overview of all the workflows, and an example of running the PBPK workflow within PLETHEM.

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CDRH Scientific Perspective on Chemical Characterization and Tox Risk Assessment for Medical Devices

Host: Medical Device and Combination Product Specialty Section (MDCPSS)

Date and Time: Wednesday, May 22, 2019, 11:00 AM–12:00 Noon (EDT)

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Chemical characterization data are used to determine the extractable or leachable substances (E/L), including degradation products, additives, impurities, and manufacturing material residuals, present in patient-contacting components of medical devices. Chemical characterization generally involves one or more extractions followed by use of multiple analytical methods with sufficient sensitivity to identify and quantify E/L that could present a toxicological concern to the patient. This talk will provide an overview of current regulatory review considerations for submissions to the US Food and Drug Administration Center for Devices and Radiological Health (CDRH) that contain chemical characterization and toxicological risk assessment. Topics covered will include methodological approaches and reporting, including extraction design, analytical instrument/tool selection, sample manipulation, system suitability, calibration, quantification/identification, and data reporting. The selection and application of the analytical evaluation threshold (AET), which is used to determine the required sensitivity of the analysis, will be discussed. When to conduct a toxicological risk assessment, as well as information to consider when assessing hazard, exposure, dose-response, and risk characterization, will be presented.

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