Regulatory Toxicology and Pharmacology : RTP This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Letter to the Editors regarding "Using historical control data in bioassays for regulatory toxicology" by Kluxen et al. (2021)
Regul Toxicol Pharmacol. 2024 Apr 6:105624. doi: 10.1016/j.yrtph.2024.105624. Online ahead of print.NO ABSTRACTPMID:38588772 | DOI:10.1016/j.yrtph.2024.105624 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - April 8, 2024 Category: Toxicology Authors: J ürg A Zarn H Christoph Geiser Sebastian L B K önig Holly V Shaw Ursina A Z ürcher Source Type: research

Biomonitoring equivalents for ethylene thiourea
Regul Toxicol Pharmacol. 2024 Apr 5:105618. doi: 10.1016/j.yrtph.2024.105618. Online ahead of print.ABSTRACTEthylene thiourea, or ETU, is used in the rubber industry and is a degradation product and impurity in some fungicides. The general public may be exposed to low concentrations of residues of ETU in a variety of ways, including food treated with ethylene bis-dithiocarbamate (EBDC) fungicides or migration from rubber products. Biomonitoring of ETU in urine is useful for an assessment of integrated exposures to ETU across different sources and routes of exposure. In this evaluation, we review available health-based risk...
Source: Regulatory Toxicology and Pharmacology : RTP - April 7, 2024 Category: Toxicology Authors: Sean M Hays Christopher R Kirman Jennifer Flippin Theresa Lopez Source Type: research

Evaluation of in silico model predictions for mammalian acute oral toxicity and regulatory application in pesticide hazard and risk assessment
Regul Toxicol Pharmacol. 2024 Apr 2:105614. doi: 10.1016/j.yrtph.2024.105614. Online ahead of print.ABSTRACTThe United States Environmental Protection Agency (USEPA) uses the lethal dose 50% (LD50) value from in vivo rat acute oral toxicity studies for pesticide product label precautionary statements and environmental risk assessment (RA). The Collaborative Acute Toxicity Modeling Suite (CATMoS) is a quantitative structure-activity relationship (QSAR)-based in silico approach to predict rat acute oral toxicity that has the potential to reduce animal use when registering a new pesticide technical grade active ingredient (TG...
Source: Regulatory Toxicology and Pharmacology : RTP - April 4, 2024 Category: Toxicology Authors: Patricia L Bishop Kamel Mansouri William P Eckel Michael B Lowit David Allen Amy Blankinship Anna B Lowit D Ethan Harwood Tamara Johnson Nicole C Kleinstreuer Source Type: research

A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document
Regul Toxicol Pharmacol. 2024 Apr 2;149:105613. doi: 10.1016/j.yrtph.2024.105613. Online ahead of print.ABSTRACTRegulatory agencies consistently deal with extensive document reviews, ranging from product submissions to both internal and external communications. Large Language Models (LLMs) like ChatGPT can be invaluable tools for these tasks, however present several challenges, particularly the proprietary information, combining customized function with specific review needs, and transparency and explainability of the model's output. Hence, a localized and customized solution is imperative. To tackle these challenges, we f...
Source: Regulatory Toxicology and Pharmacology : RTP - April 3, 2024 Category: Toxicology Authors: Leihong Wu Joshua Xu Shraddha Thakkar Magnus Gray Yanyan Qu Dongying Li Weida Tong Source Type: research

Implications of variability on medical device chemical equivalence assessment
Regul Toxicol Pharmacol. 2024 Apr 2;149:105612. doi: 10.1016/j.yrtph.2024.105612. Online ahead of print.ABSTRACTChemical equivalence testing can be used to assess the biocompatibility implications of a materials or manufacturing change for a medical device. This testing can provide a relatively facile means to evaluate whether the change may result in additional or different toxicological concerns. However, one of the major challenges in the interpretation of chemical equivalence data is the lack established criteria for determining if two sets of extractables data are effectively equivalent. To address this gap, we propos...
Source: Regulatory Toxicology and Pharmacology : RTP - April 3, 2024 Category: Toxicology Authors: David M Saylor Joshua A Young Source Type: research

A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document
Regul Toxicol Pharmacol. 2024 Apr 1:105613. doi: 10.1016/j.yrtph.2024.105613. Online ahead of print.ABSTRACTRegulatory agencies consistently deal with extensive document reviews, ranging from product submissions to both internal and external communications. Large Language Models (LLMs) like ChatGPT can be invaluable tools for these tasks, however present several challenges, particularly the proprietary information, combining customized function with specific review needs, and transparency and explainability of the model's output. Hence, a localized and customized solution is imperative. To tackle these challenges, we formu...
Source: Regulatory Toxicology and Pharmacology : RTP - April 3, 2024 Category: Toxicology Authors: Leihong Wu Joshua Xu Shraddha Thakkar Magnus Gray Yanyan Qu Dongying Li Weida Tong Source Type: research

Implications of variability on medical device chemical equivalence assessment
Regul Toxicol Pharmacol. 2024 Apr 1:105612. doi: 10.1016/j.yrtph.2024.105612. Online ahead of print.ABSTRACTChemical equivalence testing can be used to assess the biocompatibility implications of a materials or manufacturing change for a medical device. This testing can provide a relatively facile means to evaluate whether the change may result in additional or different toxicological concerns. However, one of the major challenges in the interpretation of chemical equivalence data is the lack established criteria for determining if two sets of extractables data are effectively equivalent. To address this gap, we propose a ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 3, 2024 Category: Toxicology Authors: David M Saylor Joshua A Young Source Type: research

False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test
In conclusion, ATT, which requires unnecessary animal usage and competes for resources which otherwise can be spent on innovative medicine research, should be deleted permanently as batch release test by regulatory authorities around the world.PMID:38561146 | DOI:10.1016/j.yrtph.2024.105617 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - April 1, 2024 Category: Toxicology Authors: Ryan Meng Mark van Ooij Yali Li Yunhai Zhang Jianxun Xie Source Type: research

Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology
Regul Toxicol Pharmacol. 2024 Mar 30:105616. doi: 10.1016/j.yrtph.2024.105616. Online ahead of print.ABSTRACTPharmacokinetic (PK) models are increasingly submitted to the FDA to support first-in-human (FIH) dose selection of immune-oncology products. To examine whether a simple PK modeling (SPM) using clearance for scaling was acceptable for dose estimation, FIH(SPM) doses were computed and compared to doses that were safely administered to patients. We concluded that the SPM approach is acceptable in FIH dose estimation, but the variables should be carefully selected for CD3 constructs. For CD3 constructs, use of 60 kg BW...
Source: Regulatory Toxicology and Pharmacology : RTP - April 1, 2024 Category: Toxicology Authors: Haleh Saber Matthew D Thompson John K Leighton Source Type: research

New Approach Methodologies (NAMs) for ad hoc human health risk assessment of food and non-food products - Proceedings of a workshop
Regul Toxicol Pharmacol. 2024 Mar 28:105615. doi: 10.1016/j.yrtph.2024.105615. Online ahead of print.ABSTRACTRIVM convened a workshop on the use of New Approach Methodologies (NAMs) for the ad hoc human health risk assessment of food and non-food products. Central to the workshop were two case studies of marketed products with a potential health concern: the botanical Tabernanthe iboga which is used to facilitate mental or spiritual insight or to (illegally) treat drug addiction and is associated with cardiotoxicity, and dermal creams containing female sex hormones, intended for use by perimenopausal women to reduce menopa...
Source: Regulatory Toxicology and Pharmacology : RTP - March 30, 2024 Category: Toxicology Authors: Lianne de Wit Hester Hendriks Jacqueline van Engelen Harm Heusinkveld Anne Kienhuis Emiel Rorije Marjolijn Woutersen Margriet van der Zee Suzanne Jeurissen Source Type: research