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.

Assessing the utility of common arguments used in expert review of in silico predictions as part of ICH M7 assessments
This article highlights that a relatively small number of common arguments may be used to accurately resolve many prediction scenarios to a single conclusion. The use of a standardised method of argumentation and assessment of evidence for a given impurity is proposed to improve the efficiency and consistency of expert review as part of an ICH M7 submission.PMID:37659712 | DOI:10.1016/j.yrtph.2023.105490 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - September 2, 2023 Category: Toxicology Authors: Alex N Cayley Robert S Foster Alessandro Brigo Wolfgang Muster Alyssa Musso Michelle O Kenyon Patricia Parris Angela T White Mirit Cohen-Ohana Raphael Nudelman Susanne Glowienke Source Type: research

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

Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison
This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers ...
Source: Regulatory Toxicology and Pharmacology : RTP - September 2, 2023 Category: Toxicology Authors: Fernanda Lacerda da Silva Machado Mart ín Cañás Svetlana V Doubova Mart ín A Urtasun Gustavo H Mar ín Claudia Garcia Serpa Osorio-de-Castro Flavia Caixeta Albuquerque Tatiane Bonfim Ribeiro Lisa Pont Jos é Crisóstomo-Landeros Juan Rold án-Saelzer Source Type: research

Association between metal exposure from e-cigarette components and toxicity endpoints: A literature review
Regul Toxicol Pharmacol. 2023 Aug 30:105488. doi: 10.1016/j.yrtph.2023.105488. Online ahead of print.ABSTRACTElectronic cigarette is often promoted and perceived as an 'healthy' alternative compared to conventional cigarettes. However, growing body of evidence indicate the possible adverse health effect associated with e-cigarette. Here we reviewed the literature with a focus on metal exposure in relation to e-cigarette use and related toxicity endpoints. Twenty-nine studies were identified for full text screening after applying the screening criteria of which 5 in vitro studies and 11 epidemiological studies were included...
Source: Regulatory Toxicology and Pharmacology : RTP - September 1, 2023 Category: Toxicology Authors: Jia-You Gong Manosij Ghosh Peter Hm Hoet Source Type: research

Reassessment of the cadmium toxicological reference value for use in human health assessments of foods
Regul Toxicol Pharmacol. 2023 Aug 26;144:105487. doi: 10.1016/j.yrtph.2023.105487. Online ahead of print.ABSTRACTThe U.S. Food and Drug Administration (FDA) developed an oral toxicological reference value (TRV) for characterizing potential health concerns from dietary exposure to cadmium (Cd). The development of the TRV leveraged the FDA's previously published research including (1) a systematic review for adverse health effects associated with oral Cd exposure and (2) a human physiological based pharmacokinetic (PBPK) model adapted from Kjellstrom and Nordberg (1978) for use in reverse dosimetry applied to the U.S. popula...
Source: Regulatory Toxicology and Pharmacology : RTP - August 28, 2023 Category: Toxicology Authors: Heather R Schaefer Brenna M Flannery Lynn M Crosby R égis Pouillot Sofia M Santillana Farakos Jane M Van Doren Sherri Dennis Suzanne Fitzpatrick Karlyn Middleton Source Type: research

Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum
Regul Toxicol Pharmacol. 2023 Aug 26:105483. doi: 10.1016/j.yrtph.2023.105483. Online ahead of print.ABSTRACTUnderstanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners' Forum (PF) to explore exposure considerations in human safety asse...
Source: Regulatory Toxicology and Pharmacology : RTP - August 28, 2023 Category: Toxicology Authors: Mark T D Cronin Nicholas Ball Sonja Beken Hans Bender Ofelia Bercaru Laura Caneva Marco Corvaro Richard A Currie Jeffrey L Dawson Paul Desert Sylvia E Escher Antonio Franco Amaia Irizar Jyotigna M Mehta Vera Rogiers Rapha ël T Tremblay Carl Westmoreland Source Type: research

Reassessment of the cadmium toxicological reference value for use in human health assessments of foods
Regul Toxicol Pharmacol. 2023 Aug 26:105487. doi: 10.1016/j.yrtph.2023.105487. Online ahead of print.ABSTRACTThe U.S. Food and Drug Administration (FDA) developed an oral toxicological reference value (TRV) for characterizing potential health concerns from dietary exposure to cadmium (Cd). The development of the TRV leveraged the FDA's previously published research including (1) a systematic review for adverse health effects associated with oral Cd exposure and (2) a human physiological based pharmacokinetic (PBPK) model adapted from Kjellstrom and Nordberg (1978) for use in reverse dosimetry applied to the U.S. population...
Source: Regulatory Toxicology and Pharmacology : RTP - August 28, 2023 Category: Toxicology Authors: Heather R Schaefer Brenna M Flannery Lynn M Crosby R égis Pouillot Sofia M Santillana Farakos Jane M Van Doren Sherri Dennis Suzanne Fitzpatrick Karlyn Middleton Source Type: research