Nonclinical safety assessment of epigenetic modulatory drugs: Current status and industry perspective
Publication date: November 2020Source: Regulatory Toxicology and Pharmacology, Volume 117Author(s): Vincent L. Reynolds, Paul Butler, Matthew M. Abernathy, Laura Aschenbrenner, Derek D. Best, Jim Blank, Meredith Crosby, Laura Custer, Patricia A. Escobar, Kyle Kolaja, Jonathan Moggs, Dana Shuey, Chelsea Snyder, Terry Van Vleet, Junguo Zhou, Timothy K. Hart (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 8, 2020 Category: Toxicology Source Type: research

A toxicological evaluation of monomethylsilanetriol (MMST) stabilized in acacia gum, a novel silicon preparation
Publication date: Available online 6 September 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Kayla E. Preece, Róbert Glávits, Tim Murbach, John R. Endres, Gábor Hirka, Adél Vértesi, Erzsébet Béres, Ilona Pasics Szakonyiné (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 7, 2020 Category: Toxicology Source Type: research

Safety testing of adult novelties using in vitro methods
Publication date: Available online 6 September 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): L. Svobodova, M. Dvorakova, M. Rucki, K. Kejlova, H. Kandarova, H. Kolarova, M. Mannerstrom, T. Heinonen (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 7, 2020 Category: Toxicology Source Type: research

A 26-week toxicological study of Xuezhikang (XZK), red yeast rice extract, in Beagle dogs with a 4-week recovery period
Publication date: Available online 4 September 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Chunmei Li, Yu Wang, Yonglin Gao, Hongbo Wang, Jingwei Tian, Fenghua Fu (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 5, 2020 Category: Toxicology Source Type: research

Editorial Board
Publication date: October 2020Source: Regulatory Toxicology and Pharmacology, Volume 116Author(s): (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 4, 2020 Category: Toxicology Source Type: research

Building confidence in skin sensitisation potency assessment using new approach methodologies: report of the 3rd EPAA Partners Forum, Brussels, 28th October 2019
Publication date: November 2020Source: Regulatory Toxicology and Pharmacology, Volume 117Author(s): D. Basketter, S. Beken, H. Bender, J. Bridges, S. Casati, M. Corvaro, S. Cuvellier, B. Hubesch, A. Irizar, M.N. Jacobs, P. Kern, F. Lamplmair, I. Manou, B.P. Müller, R. Roggeband, L.H. Rossi (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 4, 2020 Category: Toxicology Source Type: research

DP-2Ø2216-6 maize does not adversely affect rats in a 90-day feeding study
Publication date: Available online 2 September 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Anne B. Carlson, Pushkor Mukerji, Carey A. Mathesius, Emily Huang, Rod A. Herman, Denise Hoban, J. Dale Thurman, Jason M. Roper (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 2, 2020 Category: Toxicology Source Type: research

Letter to the editor regarding Heringa et al. (2020) paper entitled “use of the Kinetically-derived Maximum Dose concept in selection of top doses for toxicity studies hampers proper hazard assessment and risk management”
Publication date: Available online 31 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Claire Terry, Jeanne Y. Domoradzki, Carrie R. Fleming, Sean C. Gehen, Robert T. Mingoia, Lynea A. Murphy, Michael J. Bartels (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 1, 2020 Category: Toxicology Source Type: research

Prenatal developmental toxicity study of an alkaloid-free Ageratum conyzoides extract powder in rats by oral administration
Publication date: November 2020Source: Regulatory Toxicology and Pharmacology, Volume 117Author(s): Silma Subah, Nathasha Bogoda, Róbert Glávits, Ruchitha Venkatesh, Timothy S. Murbach, Kornélia Kolep-Csete (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - September 1, 2020 Category: Toxicology Source Type: research

Use of mechanistic information to derive chemical-specific adjustment factors – Refinement of risk assessment
Publication date: Available online 29 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): C. Smeraldi, A. Giarola, P.J. Aggett, P. Moldeus, U. Gundert-Remy (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - August 30, 2020 Category: Toxicology Source Type: research

Iraqi regulatory authority current system and experience with biosimilars
Publication date: Available online 27 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Khalid K. Al-Kinani, Mazin J. Ibrahim, Ruaa F. Al-Zubaidi, Manal M. Younus, Samir H. Ramadhan, Hussein J. Kadhim, Rodeina Challand (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - August 29, 2020 Category: Toxicology Source Type: research

Building confidence in skin sensitisation potency assessment using new approach methodologies report of the 3rd EPAA Partners Forum, Brussels, 28th October 2019
Publication date: Available online 28 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): D. Basketter, S. Beken, H. Bender, J. Bridges, S. Casati, M. Corvaro, S. Cuvellier, B. Hubesch, A. Irizar, M.N. Jacobs, P. Kern, F. Lamplmair, I. Manou, B.P. Müller, R. Roggeband, L.H. Rossi (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - August 29, 2020 Category: Toxicology Source Type: research

Development of peptide therapeutics: A nonclinical safety assessment perspective
Publication date: Available online 19 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Mayur S. Mitra, Steven DeMarco, Brad Holub, Lakshmanan Thiruneelakantapillai, Evan A. Thackaberry (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - August 20, 2020 Category: Toxicology Source Type: research

Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations
Publication date: Available online 19 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Gary Gintant, Emily Pfeiffer Kaushik, Tromondae Feaster, Sonja Stoelzle-Feix, Yasunari Kanda, Tomoharu Osada, Godfrey Smith, Katherine Czysz, Ralf Kettenhofen, Hua Rong Lu, Beibei Cai, Hong Shi, Todd Joseph Herron, Qianyu Dang, Francis Burton, Li Pang, Martin Traebert, Yama Abassi, Jennifer Beck Pierson, Ksenia Blinova (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - August 19, 2020 Category: Toxicology Source Type: research

Weight of evidence and human relevance evaluation of the benfluralin mode of action in rodents (Part I): Liver carcinogenesis
Publication date: Available online 14 August 2020Source: Regulatory Toxicology and PharmacologyAuthor(s): Christian Strupp, Nicolas Quesnot, Lysiane Richert, Joanna Moore, Werner H. Bomann, Pramila Singh (Source: Regulatory Toxicology and Pharmacology)
Source: Regulatory Toxicology and Pharmacology - August 15, 2020 Category: Toxicology Source Type: research