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.

Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies
Regul Toxicol Pharmacol. 2024 Apr 27;150:105632. doi: 10.1016/j.yrtph.2024.105632. Online ahead of print.ABSTRACTThe replacement of a proportion of concurrent controls by virtual controls in nonclinical safety studies has gained traction over the last few years. This is supported by foundational work, encouraged by regulators, and aligned with societal expectations regarding the use of animals in research. This paper provides an overview of the points to consider for any institution on the verge of implementing this concept, with emphasis given on database creation, risks, and discipline-specific perspectives.PMID:38679316...
Source: Regulatory Toxicology and Pharmacology : RTP - April 28, 2024 Category: Toxicology Authors: Xavier Palazzi Lennart T Anger Theresa Boulineau Armelle Grevot Magali Guffroy Kristin Henson Natalie Hoepp Matt Jacobsen Vijay P Kale John Kreeger Joan H Lane Dingzhou Li Wolfgang Muster Brianna Paisley Lila Ramaiah Nicola Robertson Valerie Shultz Thomas Source Type: research

Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies
Regul Toxicol Pharmacol. 2024 Apr 26:105632. doi: 10.1016/j.yrtph.2024.105632. Online ahead of print.ABSTRACTThe replacement of a proportion of concurrent controls by virtual controls in nonclinical safety studies has gained traction over the last few years. This is supported by foundational work, encouraged by regulators, and aligned with societal expectations regarding the use of animals in research. This paper provides an overview of the points to consider for any institution on the verge of implementing this concept, with emphasis given on database creation, risks, and discipline-specific perspectives.PMID:38679316 | D...
Source: Regulatory Toxicology and Pharmacology : RTP - April 28, 2024 Category: Toxicology Authors: Xavier Palazzi Lennart T Anger Theresa Boulineau Armelle Grevot Magali Guffroy Kristin Henson Natalie Hoepp Matt Jacobsen Vijay P Kale John Kreeger Joan H Lane Dingzhou Li Wolfgang Muster Brianna Paisley Lila Ramaiah Nicola Robertson Valerie Shultz Thomas Source Type: research

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;150:105629. 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)....
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

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