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Specialty: Toxicology
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Total 645 results found since Jan 2013.
On the development of physiologically based toxicokinetic models (PBTK) for cardiovascular implants
Regul Toxicol Pharmacol. 2023 Aug 31:105489. doi: 10.1016/j.yrtph.2023.105489. Online ahead of print.ABSTRACTLocal and systemic contamination caused by metal ions leaching from medical device materials is a significant and continuing health problem. The increasing need for verification and validation, and the imposition of stringent government regulations to ensure that the products comply with the quality, safety, and performance standards, have led regulatory bodies worldwide to strongly recommend the use of modeling and simulation tools to support medical device submissions. A previously published physiologically-based ...
Source: Regulatory Toxicology and Pharmacology : RTP - September 2, 2023 Category: Toxicology Authors: Matheos Giakoumi Pavlos S Stephanou Konstantinos Kapnisis Andreas Anayiotos Source Type: research
Setting the stage to advance oil toxicity testing: Overview of knowledge gaps, and recommendations
Aquat Toxicol. 2023 May 16;261:106581. doi: 10.1016/j.aquatox.2023.106581. Online ahead of print.ABSTRACTThe Chemical Response to Oil Spills: Ecological Effects Research Forum created a standardized protocol for comparing the in vivo toxicity of physically dispersed oil to chemically dispersed oil to support science-based decision making on the use of dispersants in the early 2000s. Since then, the protocol has been frequently modified to incorporate advances in technology; enable the study of unconventional and heavier oils; and provide data for use in a more diverse manner to cover the growing needs of the oil spill scie...
Source: Aquatic Toxicology - June 7, 2023 Category: Toxicology Authors: Jennifer R Loughery Gina M Coelho Kenneth Lee Benjamin de Jourdan Source Type: research
Advances to the CROSERF protocol to improve oil spill response decision making
Aquat Toxicol. 2023 May 16;260:106580. doi: 10.1016/j.aquatox.2023.106580. Online ahead of print.ABSTRACTThe Chemical Response to Oil Spills: Ecological Effects Research Forum (CROSERF) created a standardized protocol for comparing the toxicity of physically dispersed oil versus chemically dispersed oil to address environmental concerns related to the proposed use of dispersants in the early 2000s. Since then, many revisions have been made to the original protocol to diversify the intended use of the data generated, incorporate emerging technologies, and to examine a wider range of oil types including non-conventional oils...
Source: Aquatic Toxicology - May 27, 2023 Category: Toxicology Authors: Kenneth Lee Gina Coelho Jennifer Loughery Benjamin de Jourdan Source Type: research
Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies
Regul Toxicol Pharmacol. 2023 Feb 4:105345. doi: 10.1016/j.yrtph.2023.105345. Online ahead of print.ABSTRACTPreviously, we provided an FDA/CDER perspective on nonclinical testing strategies and briefly discussed the opportunities and challenges of using new approach methodologies (NAMs) in drug development, especially for regulatory purposes. To facilitate the integration of NAMs into nonclinical regulatory testing, we surveyed the CDER Pharmacology/Toxicology community to identify the nonclinical challenges faced by CDER review staff, including gaps and areas of concern underserved by current nonclinical testing approache...
Source: Regulatory Toxicology and Pharmacology : RTP - February 6, 2023 Category: Toxicology Authors: Amy M Avila Ilona Bebenek Donna L Mendrick Jackye Peretz Jia Yao Paul C Brown Source Type: research
Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays
Regul Toxicol Pharmacol. 2022 Mar 17:105160. doi: 10.1016/j.yrtph.2022.105160. Online ahead of print.ABSTRACTRodent cancer bioassays have been long-required studies for regulatory assessment of human cancer hazard and risk. These studies use hundreds of animals, are resource intensive, and certain aspects of these studies have limited human relevance. The past 10 years have seen an exponential growth of new technologies with the potential to effectively evaluate human cancer hazard and risk while reducing, refining, or replacing animal use. To streamline and facilitate uptake of new technologies, a workgroup comprised of s...
Source: Regulatory Toxicology and Pharmacology : RTP - March 21, 2022 Category: Toxicology Authors: Gina M Hilton Catherine Adcock Gregory Akerman James Baldassari Michael Battalora Warren Casey Amy J Clippinger Rhian Cope Amber Goetz A Wallace Hayes Sabitha Papineni Richard C Peffer Deborah Ramsingh Brandy Williamson Riffle Mitscheli Sanches da Rocha N Source Type: research
"From Protein Toxins to Applied Toxicological Testing" virtual workshop identifies the need for a bioinformatic framework to assess novel food protein safety
Regul Toxicol Pharmacol. 2022 Feb 24:105146. doi: 10.1016/j.yrtph.2022.105146. Online ahead of print.ABSTRACTOn October 21-22, 2020 the HESI (Health and Environmental Science Institute) Protein Allergens, Toxins, and Bioinformatics Committee, and the Society of Toxicology Food Safety Specialty Section co-hosted a virtual workshop titled "From Protein Toxins to Applied Toxicological Testing". The workshop focused on the safety assessment of novel proteins contained in foods and feeds, was globally represented by over 200 stakeholder attendees, and featured contributions from experts in academia, government and non-governmen...
Source: Regulatory Toxicology and Pharmacology : RTP - February 27, 2022 Category: Toxicology Authors: Patricia A Bauman Andrew C Doxey Ivano Eberini Emir Islamovic Florence Jungo Colton Kessenich John Kough Mansi Krishan Luca Palazzolo Laura Privalle Chester Rodriguez Karla Satchell Andre Silvanovich Lucilia Pereira Mouri ès Source Type: research
