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.

In silico evaluation of the potential allergenicity of a fungal biomass from Rhizomucor pusillus for use as a novel food ingredient
Regul Toxicol Pharmacol. 2024 Apr 22:105629. doi: 10.1016/j.yrtph.2024.105629. Online ahead of print.ABSTRACTThe world's hunger for novel food ingredients drives the development of safe, sustainable, and nutritious novel food products. For foods containing novel proteins, potential allergenicity of the proteins is a key safety consideration. One such product is a fungal biomass obtained from the fermentation of Rhizomucor pusillus. The annotated whole genome sequence of this strain was subjected to sequence homology searches against the AllergenOnline database (sliding 80-amino acid windows and full sequence searches). In ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 24, 2024 Category: Toxicology Authors: Kevin Scaife Steve L Taylor Lucie Pa řenicová Richard E Goodman Trung D Vo Elisa Leune Mohamed Abdelmoteleb Yvonne Dommels Source Type: research

A roadmap towards a human-centric safety assessment of advanced therapy medicinal products
Regul Toxicol Pharmacol. 2024 Apr 20:105631. doi: 10.1016/j.yrtph.2024.105631. Online ahead of print.ABSTRACTAdvanced therapy medicinal products (ATMPs) are among the most complex pharmaceuticals with high human specificity. Species differences severely limit the clinical relevance of in vivo data. We conducted interviews with stakeholders involved in ATMP development about their perspective on the use of in vivo studies, the perceived hurdles and associated potential solutions regarding non-clinical development of ATMPs. In total, 17 stakeholders from 9 different countries were interviewed. A workshop was held with key st...
Source: Regulatory Toxicology and Pharmacology : RTP - April 22, 2024 Category: Toxicology Authors: Hsiao-Tzu Chien Victoria C de Leeuw Joantine C J van Esterik Frans G M Russel Anne S Kienhuis Peter T Theunissen Peter van Meer Source Type: research

Challenges and Gaps in Immunosafety Evaluation of Therapeutics: An IQ DruSafe Survey
Regul Toxicol Pharmacol. 2024 Apr 18:105630. doi: 10.1016/j.yrtph.2024.105630. Online ahead of print.ABSTRACTImmunotoxicology/immunosafety science is rapidly evolving, with novel modalities and immuno-oncology among the primary drivers of new tools and technologies. The Immunosafety Working Group of IQ/DruSafe sought to better understand some of the key challenges in immunosafety evaluation, gaps in the science, and current limitations in methods and data interpretation. A survey was developed to provide a baseline understanding of the needs and challenges faced in immunosafety assessments, the tools currently being applie...
Source: Regulatory Toxicology and Pharmacology : RTP - April 20, 2024 Category: Toxicology Authors: Mark Collinge Haley Neff-LaFord Surekha Akella Birgit Fogal Kathryn Fraser Jacob Jabbour Kirsty Harper Curtis C Maier Laurent Malherbe Nikki Marshall Gautham K Rao Kavita Raman Hollie Skaggs Felix Weber Claudette L Fuller Source Type: research

Biosimilars production in Africa opportunities & amp; challenges
Regul Toxicol Pharmacol. 2024 Apr 16;149:105626. doi: 10.1016/j.yrtph.2024.105626. Online ahead of print.ABSTRACTThe healthcare systems of African nations heavily rely on importing and repackaging biological medicine. More than 70% of the pharmaceutical products consumed in Africa are imported. The localization of biosimilar production can have a positive impact on the availability and cost of these products by reducing the expenses for African governments and making essential healthcare products more accessible to the population. However, it is evident that the developing countries, particularly African nations, face vari...
Source: Regulatory Toxicology and Pharmacology : RTP - April 18, 2024 Category: Toxicology Authors: Amany E Abdel-Maged Margrit F Mikhaeil Ahmed I Elkordy Amany M Gad Mohamed M Elshazly Source Type: research

Benchmarking of BMDC assay and related QSAR study for identifying sensitizing chemicals
This study expanded the BMDC benchmarking to various in vitro, in chemico, and in silico assays targeting different key events (KE) in the skin sensitization pathway, using common substances datasets. Additionally, a Quantitative Structure-Activity Relationship (QSAR) model was developed to predict the BMDC test outcomes for sensitizing or non-sensitizing chemicals. The modeling workflow involved ISIDA (In Silico Design and Data Analysis) molecular fragment descriptors and the SVM (Support Vector Machine) machine-learning method. The BMDC model's performance was at least comparable to that of all ECVAM-validated models reg...
Source: Regulatory Toxicology and Pharmacology : RTP - April 17, 2024 Category: Toxicology Authors: Lisa Chedik Shamkhal Baybekov Gilles Marcou Fr édéric Cosnier M élanie Mourot-Bousquenaud Sandrine Jacquenet Alexandre Varnek Fabrice Battais Source Type: research

Benchmarking of BMDC Assay and related QSAR Study for Identifying Sensitizing Chemicals
This study expanded the BMDC benchmarking to various in vitro, in chemico, and in silico assays targeting different key events (KE) in the skin sensitization pathway, using common substances datasets. Additionally, a Quantitative Structure-Activity Relationship (QSAR) model was developed to predict the BMDC test outcomes for sensitizing or non-sensitizing chemicals. The modelling workflow involved ISIDA (In Silico Design and Data Analysis) molecular fragment descriptors and the SVM (Support Vector Machine) machine-learning method. The BMDC model's performance was at least comparable to that of all ECVAM-validated models re...
Source: Regulatory Toxicology and Pharmacology : RTP - April 17, 2024 Category: Toxicology Authors: Lisa Chedik Shamkhal Baybekov Gilles Marcou Fr édéric Cosnier M élanie Mourot-Bousquenaud Sandrine Jacquenet Alexandre Varnek Fabrice Battais Source Type: research

Ambient air concentrations of Plant Protection Products: data collection for the Combined Air Concentration Database and associated risk assessment
In conclusion, based on the CACD, measured air concentrations of PPPs are significantly lower than EFSA default limits and relevant toxicological reference values.PMID:38621522 | DOI:10.1016/j.yrtph.2024.105627 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - April 15, 2024 Category: Toxicology Authors: Anne-Kim Vinck Edgars Felkers Michel Urtizberea Nicola J Hewitt Kathrin B ürling Alistair Morriss Source Type: research

Proposals for new transfer coefficient (TC) values for worker re-entry activities in grape vineyards
Regul Toxicol Pharmacol. 2024 Apr 13:105628. doi: 10.1016/j.yrtph.2024.105628. Online ahead of print.ABSTRACTNew transfer coefficient (TC) values were derived for vineyard workers handling treated grapevines during harvesting and crop maintenance activities. Re-entry exposure and dislodgeable foliar residue (DFR) studies were performed in Europe, covering hand harvesting, pruning/training, pruning/tying and pruning /shoot lifting. Foliar applications of fungicides (iprovalicarb, dimethomorph, dithianon, pyrimethanil and fenbuconazole) were made and 73 workers at 16 sites were monitored over one working day. Exposure was me...
Source: Regulatory Toxicology and Pharmacology : RTP - April 15, 2024 Category: Toxicology Authors: Udo Blaschke Edgars Felkers Nicola J Hewitt Felix M Kluxen Neil Morgan Christiane Wiemann Source Type: research

Safety assessment of Paeonia lactiflora root extract for a cosmetic ingredient employing the threshold of toxicological concern (TTC) approach
Regul Toxicol Pharmacol. 2024 Apr 12:105620. doi: 10.1016/j.yrtph.2024.105620. Online ahead of print.ABSTRACTBotanical extracts, widely used in cosmetics, pose a challenge to safety assessment due to their complex compositions. The threshold of toxicological concern (TTC) approach, offering a safe exposure level for cosmetic ingredients, proves to be a promising solution for ensuring the safety of cosmetic ingredients with low exposure level. We assessed the safety of Paeonia lactiflora root extract (PLR), commonly used in skin conditioning products, with the TTC. We identified 50 constituents of PLR extract from the USDA ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 14, 2024 Category: Toxicology Authors: Soha Jeon Eun-Young Lee Sang-Jip Nam Kyung-Min Lim Source Type: research

How the Xenopus eleutheroembryonic thyroid assay compares to the amphibian metamorphosis assay for detecting thyroid active chemicals
This study was therefore initiated to investigate and consolidate the applicability domain of the XETA regarding the following mechanisms: thyroid hormone receptor (THR) agonism, sodium-iodide symporter (NIS) inhibition, thyroperoxidase (TPO) inhibition, deiodinase (DIO) inhibition, glucocorticoid receptor (GR) agonism, and uridine 5'-diphospho-glucuronosyltransferase (UDPGT) induction. In total, 22 chemicals identified as thyroid-active or -inactive in Amphibian Metamorphosis Assays (AMAs) were tested using the XETA OECD Test Guideline. The comparison showed that both assays are highly concordant in identifying chemicals ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 13, 2024 Category: Toxicology Authors: David Du Pasquier Beno ît Salinier Katherine K Coady Alan Jones Oliver K örner Jessica LaRocca Gregory Lemkine Barbara Robin-Duchesne Lennart Weltje James R Wheeler Laurent Lagadic Source Type: research

Safety Evaluation of 8 Drug Degradants Present in Over-the-Counter Cough and Cold Medications
Regul Toxicol Pharmacol. 2024 Apr 10:105621. doi: 10.1016/j.yrtph.2024.105621. Online ahead of print.ABSTRACTAlthough the United States Food & Drug Administration (FDA) has provided guidance on the control of drug degradants for prescription drugs, there is less guidance on how to set degradant specifications for FDA OTC monograph drugs. Given that extensive impurity testing was not part of the safety paradigm in original OTC monographs, a weight of evidence (WOE) approach to qualify OTC degradants is proposed. This approach relies on in silico tools and read-across approaches alongside standard toxicity testing to det...
Source: Regulatory Toxicology and Pharmacology : RTP - April 12, 2024 Category: Toxicology Authors: Amy L Mihalchik Neepa Y Choksi Amy L Roe Michael Wisser Kylen Whitaker Donna Seibert Milind Deore Larisa Pavlick Daniele S Wikoff Source Type: research