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ToxStrategies’ scientists Camarie Perry, Stephanie Vivanco, Ann Holbrow Verwiel, and Deborah Proctor conducted a regulatory and scientific literature review to develop an acute/short-term inhalation guideline for manganese in ambient air, protective of respiratory effects and neurotoxicity. To reduce uncertainty regarding manganese accumulation in the brain from short-term exposures, the authors used previously published physiologically-based pharmacokinetic (PBPK) modelling to support that the derived 24-h inhalation guideline of 5 μg/m3 is protective for sensitive life-stages. As very read more…

ToxStrategies’ scientists will be participating in The Society of Environmental Toxicology and Chemistry’s (SETAC) 44th Annual Meeting this year, November 12–16, in Louisville, Kentucky. In addition to the many presentations listed below, Dr. Bill Rish of will co-chair the session titled “Methods and Data for Cumulative Impact Assessment in the Context of Environmental Justice.” Featured Presenters: Alexander East, William Klaren, Cara Frankenfeld, William Rish – Evaluating Biometrics in National Health and Nutrition Survey (NHANES) Data read more…

HEORStrategies provides robust, strategic health economics and outcomes research (HEOR) consulting services to pharma, biotech, and medical device clients!

EpidStrategies’ scientists are recognized experts in the field of respiratory syncytial virus (RSV). Our RSV research program supported the newly-approved monoclonal antibody with our studies being cited by the CDC (https://www.cdc.gov/vaccines/acip/recs/grade/nirsevimab-season2-rsv-infants-children-etr.html ). Mina Suh, Naimisha Movva, Heidi Reichert, and Xiaohui Jiang, along with clinicians and industry leaders, are presenting two RSV studies at IDWeek on October 11-15, 2023. Seasonality of infant respiratory syncytial virus associated bronchiolitis around the US since the onset of COVID-19: Results read more…

ToxStrategies scientist Dr. Rayetta Henderson is among the authors of two new articles published by the journal Cannabis and Cannabinoid Research. Together, these studies present the outcome of short-term preclinical toxicity studies of five minor cannabinoids in rats. The results of these studies demonstrate that cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), delta-8-tetrahydrocannabinol (D8-THC), and tetrahydrocannabivarin (THCV) were well tolerated at the respective doses tested for each, over a two-week period. This preliminary work will support read more…

ToxStrategies scientists have published a manuscript in the journal Regulatory Toxicology and Pharmacology reporting the outcome of a state-of-the-science assessment to develop recommendations for oral consumer use of hemp-derived cannabidiol (CBD) isolate. Using a systematic approach to review the publicly available human and animal safety data on CBD, a potential acceptable daily intake (ADI) value was derived for the general population and from all sources, as were recommended upper intake limits (ULs) for dietary supplement read more…

We are thrilled to announce that Dr. Fernando Sampedro has joined ToxStrategies LLC, bringing his broad expertise and depth of experience to our Foods and Consumer Products practice. With more than 15 years of experience in food safety and risk assessment, Dr. Sampedro further strengthens our team of top-tier scientific consultants. Dr. Sampedro is a bilingual (Spanish/English) food scientist with in-depth knowledge of the Food Safety Modernization Act (FSMA) and its regulatory requirements; microbial food safety, read more…

EpidStrategies, a Division of ToxStrategies LLC, is pleased to announce the addition of Dr. Michael Kelsh to our team, adding considerable depth to our qualifications in the fields of pharmacoepidemiology and occupational/environmental health. Dr. Kelsh brings to EpidStrategies 30+ years of experience in observational research and epidemiologic study design and implementation in the pharma, occupational and environmental health sectors. While working in the pharmaceutical/biotechnology industry, Dr Kelsh collaborated with clinical development, safety, and regulatory teams read more…