Results 241 to 250 of about 2,895,352 (324)

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

Clinical Pharmacology &Therapeutics, EarlyView.
The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard, Marko J. Kallio, Luca Kosec, Ulrika Espefält Westin, on behalf of the IncreaseNET consortium   +4 more
wiley   +1 more source

Family's socioeconomic and demographic factors on elements of children's dental and oral health: A scoping review

Clinical and Experimental Dental Research, EarlyView.
Abstract Background Family plays a significant role in children's dental and oral health (DOH) elements, such as children's DOH knowledge and practice, the development of children's dental fear and anxiety (DFA), children's dental visits, and children's DOH status.
Wisnu Fadila, Mugia B. Rahardja, Puguh Prasetyoputra, Anne A. Suwargiani, Yanu E. Prasetyo, Eriska Riyanti   +5 more
wiley   +1 more source

Reduced Oligodendrocyte Density and Axonal Caliber Associated With Mitochondrial Alterations in the White Matter of Chronically‐Starved Mice

International Journal of Eating Disorders, EarlyView.
ABSTRACT Objective Anorexia nervosa (AN) is a severe eating disorder associated with extreme weight loss, hyperactivity, and amenorrhea. Neuroimaging studies revealed brain atrophy and disruption of white matter integrity in the corpus callosum (CC) of patients with AN. However, the underlying pathophysiological mechanisms remain unclear.
Stephan Lang, Annelie Zimmermann, Kaja Dickert, Hanna Rupprecht, Julia Priebe, Fabienne Haberland, Hanna‐Sophia Henschke, Katharina Schuster, Marcus Frank, Linda Frintrop   +9 more
wiley   +1 more source

Interpretation of in vitro concentration‐response data for risk assessment and regulatory decision‐making: Report from the 2022 IWGT quantitative analysis expert working group meeting

Environmental and Molecular Mutagenesis, EarlyView.
Abstract Quantitative risk assessments of chemicals are routinely performed using in vivo data from rodents; however, there is growing recognition that non‐animal approaches can be human‐relevant alternatives. There is an urgent need to build confidence in non‐animal alternatives given the international support to reduce the use of animals in toxicity ...
Marc A. Beal, Guangchao Chen, Kerry L. Dearfield, Min Gi, Bhaskar Gollapudi, Robert H. Heflich, Katsuyoshi Horibata, Alexandra S. Long, David P. Lovell, Barbara L. Parsons, Stefan Pfuhler, John Wills, Andreas Zeller, George Johnson, Paul A. White   +14 more
wiley   +1 more source

Severity of effect considerations regarding the use of mutation as a toxicological endpoint for risk assessment: A report from the 8th International Workshop on Genotoxicity Testing (IWGT)

Environmental and Molecular Mutagenesis, EarlyView.
Abstract Exposure levels without appreciable human health risk may be determined by dividing a point of departure on a dose–response curve (e.g., benchmark dose) by a composite adjustment factor (AF). An “effect severity” AF (ESAF) is employed in some regulatory contexts.
Barbara L. Parsons, Marc A. Beal, Kerry L. Dearfield, George R. Douglas, Min Gi, B. Bhaskar Gollapudi, Robert H. Heflich, Katsuyoshi Horibata, Michelle Kenyon, Alexandra S. Long, David P. Lovell, Anthony M. Lynch, Meagan B. Myers, Stefan Pfuhler, Alisa Vespa, Andreas Zeller, George E. Johnson, Paul A. White   +17 more
wiley   +1 more source

Epigenotoxicity: Decoding the epigenetic imprints of genotoxic agents and their implications for regulatory genetic toxicology

Environmental and Molecular Mutagenesis, EarlyView.
Abstract Regulatory genetic toxicology focuses on DNA damage and subsequent gene mutations. However, genotoxic agents can also affect epigenetic marks, and incorporation of epigenetic data into the regulatory framework may thus enhance the accuracy of risk assessment.
Roger Godschalk, Christopher Faulk, Jessica LaRocca, Jan van Benthem, Francesco Marchetti   +4 more
wiley   +1 more source

Evaluation of the standard battery of in vitro genotoxicity tests to predict in vivo genotoxicity through mathematical modeling: A report from the 8th International Workshop on Genotoxicity Testing

Environmental and Molecular Mutagenesis, EarlyView.
Abstract In human health risk assessment of chemicals and pharmaceuticals, identification of genotoxicity hazard usually starts with a standard battery of in vitro genotoxicity tests, which is needed to cover all genotoxicity endpoints. The individual tests included in the battery are not designed to pick up all endpoints.
Mirjam Luijten, Jan van Benthem, Takeshi Morita, Raffaella Corvi, Patricia A. Escobar, Yurika Fujita, Jennifer Hemmerich, Naveed Honarvar, David Kirkland, Naoki Koyama, David P. Lovell, Miriam Mathea, Andrew Williams, Stephen Dertinger, Stefan Pfuhler, Jeroen L. A. Pennings   +15 more
wiley   +1 more source

Complete genome sequence of <i>Pediococcus pentosaceus</i> 5.5 8-1 isolated from a pasture-kept Holstein Friesian cattle. [PDF]

Microbiol Resour Announc
Titgemeyer F, Mariani Corea N, Meyer F, Fischer SW.   +3 more
europepmc   +1 more source

Consensus findings of an International Workshops on Genotoxicity Testing workshop on using transcriptomic biomarkers to predict genotoxicity

Environmental and Molecular Mutagenesis, EarlyView.
Abstract Gene expression biomarkers have the potential to identify genotoxic and non‐genotoxic carcinogens, providing opportunities for integrated testing and reducing animal use. In August 2022, an International Workshops on Genotoxicity Testing (IWGT) workshop was held to critically review current methods to identify genotoxicants using ...
Roland Froetschl, J. Christopher Corton, Henghong Li, Jiri Aubrecht, Scott S. Auerbach, Florian Caiment, Tatyana Y. Doktorova, Yurika Fujita, Danyel Jennen, Naoki Koyama, Matthew J. Meier, Roman Mezencev, Leslie Recio, Takayoshi Suzuki, Carole L. Yauk   +14 more
wiley   +1 more source

Review of Transcriptomic Biomarkers That Predict In Vitro Genotoxicity in Human Cell Lines

Environmental and Molecular Mutagenesis, EarlyView.
ABSTRACT The current genotoxicity testing paradigm provides little mechanistic information, has poor specificity in predicting carcinogenicity in humans, and is not suited to assessing a large number of chemicals. Genomic technologies enable the characterization of genome‐wide transcriptional changes in response to chemical treatments that can inform ...
Heng‐Hong Li, Jiri Aubrecht, Tatyana Y. Doktorova, Danyel Jennen, J. Christopher Corton, Roland Froetschl, Roman Mezencev, Carole L. Yauk   +7 more
wiley   +1 more source