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Innovation and Adversity in Spine Surgery: A Retrospective.
Int J Spine Surg
March 2025
Atrium Health, Spine Center of Excellence, Charlotte, NC, USA
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology.
Regul Toxicol Pharmacol
March 2025
Drug Disposition, Toxicology and PKPD, Eli Lilly and Company, Indianapolis, IN 46285, USA. Electronic address:
Although the ICH S7A guideline on safety pharmacology largely achieved its objective, a proportion of remaining adverse drug reactions and attrition can be attributed in part to gaps in safety and secondary pharmacology assessments. Advances in science, technology, drug development paradigm and regulatory practices necessitate revisiting and evolving ICH S7A to address these limitations. The anticipated completion of the ICH S7B Q&As by end of 2025 provides an opportunity to integrate its outcomes with ICH S7A into a comprehensive, modality-agnostic sustainable over time framework.
View Article and Find Full Text PDFPerson-centered analyses reveal that developmental adversity at moderate levels and neural threat/safety discrimination are associated with lower anxiety in early adulthood.
Commun Psychol
March 2025
Department of Psychology, Yale University, New Haven, CT, USA.
Parsing heterogeneity in the nature of adversity exposure and neurobiological functioning may facilitate better understanding of how adversity shapes individual variation in risk for and resilience against anxiety. One putative mechanism linking adversity exposure with anxiety is disrupted threat and safety learning. Here, we applied a person-centered approach (latent profile analysis) to characterize patterns of adversity exposure at specific developmental stages and threat/safety discrimination in corticolimbic circuitry in 120 young adults.
View Article and Find Full Text PDFImpact of life adversity and gene expression on psychiatric symptoms in children and adolescents: findings from the Brazilian high risk cohort study.
Front Psychiatry
February 2025
Laboratory of Integrative Neuroscience (LiNC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
Introduction: While the influence of both genetic and environmental factors on the development of psychiatric symptoms is well-recognized, the precise nature of their interaction throughout development remains a subject of ongoing debate. This study investigated the association between the expression of 78 candidate genes, previously associated with psychiatric phenotypes, in peripheral blood and both adversity and psychopathology in a sample of 298 young individuals assessed at two time points from the Brazilian High Risk Cohort Study for Mental Conditions (BHRCS).
Methods: Psychopathology was assessed using the Child Behavior Checklist (CBCL), considering the total CBCL, p-factor (i.
Childhood socioeconomic position and healthy ageing: results from five harmonised cohort studies in the ATHLOS consortium.
BMJ Public Health
January 2025
Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
Introduction: Childhood socioeconomic position (SEP) has been identified as a key determinant of health. However, earlier literature is largely from high-income countries and provides limited evidence on the prolonging impacts of childhood disadvantage on healthy ageing across diverse settings and populations. The aim of this study is to investigate the associations between childhood SEP and healthy ageing across multiple countries and the mediation effects of adult SEP, individual education and wealth, on these associations.
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