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USEPA released the second set of Scope Documents for chemicals undergoing risk evaluation under TSCA and is soliciting public comment.  Those seven chemicals include:  Butyl benzyl phthalate,  Dibutyl phthalate, Dicyclohexyl phthalate, Di-ethylhexyl phthalate, Di-isobutyl phthalate, Formaldehyde, Phthalic anhydride. Links to these chemicals can be found at:  https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemicals-undergoing-risk-evaluation-under-tsca.

ToxStrategies’ scientists have proposed potential expansions of the use cases for the threshold of toxicological concern (TTC) in human health risk assessment applications. Analyses indicate that conservative TTC values for chemicals are, on average, approximately six-fold lower than IRIS derived reference dose (RfD) values for noncancer effects. The findings have three potential applications: (1) serve as provisional toxicity values estimated from TTC Cramer Classifications in data-poor or emergency situations, (2) serve as a comparator for read more…

ToxStrategies scientists have the following e-posters available for viewing via the SOT Virtual Meeting Program.   Please click on the poster to view abstract and full poster. Dr. Ali Chesney, lead author on The Process and Challenges of Deriving Exposure-Based Limits for Toxicological Risk Assessment for Components and Impurities Present in Cell Therapy Products with Case Studies Dr. Allison Franzen, lead author on An Adverse Outcome Pathway for Renal Tumors in Male Rats through Chemical read more…

Over the next several months, the Society of Toxicology will host live webinars of sessions and courses originally scheduled for the 2020 SOT Annual Meeting. Information on confirmed webinars and registration details can be found here.

Due to concerns over COVID-19 (Coronavirus), the Texas Commission on Environmental Quality has canceled the 2020 Environmental Trade Fair & Conference. Next’s years Trade Fair & Conference is tentatively scheduled for May 11-12, 2021.  

This week, FDA released guidance for sponsors conducting clinical trials on how to manage ongoing and planned activities. This guidance emphasizes patient safety and communication.   FDA noted that the decisions about continuing with patient recruitment and treatment, implementing alternative options for patient monitoring or visits, or discontinuing a trial may depend on specific, individual circumstances. Changes or missing information with regard to COVID-19 should be well documented, and the clinical study report should describe contingency read more…

Job Description ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 3 years in biopharmaceutical/pharmaceutical experience, in industry, government [FDA], or Contract Research Organizations [CROs]), to join our expanding Biopharmaceutical/Pharmaceutical consulting practice. ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Biopharmaceutical/Pharmaceutical Practice provide consulting services to pharmaceutical companies in all phases of the drug development process. read more…

Job Description ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 7–10 years experience in in biopharmaceutical/pharmaceutical consulting and/or industry or government [e.g., FDA]) to join our expanding Biopharmaceutical/Pharmaceutical consulting practice. ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Biopharmaceutical/Pharmaceutical Practice provide consulting services to companies in all phases of the drug development process. This includes read more…