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Opportunities for More Tailored Approaches to Genotoxicity Testing and Carcinogenicity Strategy for Oligonucleotide Therapeutics: Outcome of an Industry Survey.
Nucleic Acid Ther
January 2025
Global Preclinical Safety, AbbVie Inc., North Chicago, Illinois, USA.
The Oligonucleotide Nonclinical Working Group (WG) of the European Federation of Pharmaceutical Industries and Associations conducted an industry survey to understand current practices and regulatory expectations for genotoxicity and carcinogenicity assessment of oligonucleotide therapeutics (ONTs), along with historical genotoxicity testing results. The survey, involving 29 pharmaceutical and biotechnology companies, revealed a consistent absence of genotoxicity across a diverse range of oligonucleotide classes and chemistries, consistent with previous observations. Despite the lack of genotoxicity, companies continue to follow standard testing guidelines, with only limited divergence.
View Article and Find Full Text PDFTranslation, validation, and reliability of the Modified Occupational Questionnaire into Bahasa Melayu among older persons in Malaysia.
Aust Occup Ther J
February 2025
Centre for Rehabilitation and Special Needs Studies, Occupational Therapy Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, 50300, Malaysia.
Introduction: A Modified Occupational Questionnaire (MOQ) is a self-report questionnaire that records the occupational engagement of an individual hourly, focusing on activity category, reason for doing the activity, value to self, and value to society. Understanding the patterns of occupational engagement and meaningful time use in older persons is crucial for predicting physical and psychological health and establishing occupation-based interventions to support healthy aging. However, the MOQ, originally developed in an English-speaking country and may potentially be less suitable for Malaysian older persons, who are predominantly Malay-speaking and have distinct cultural adaptations.
View Article and Find Full Text PDFQuality and Regulatory Requirements for the Manufacture of Master Cell Banks of Clinical Grade iPSCs: The EU and USA Perspectives.
Stem Cell Rev Rep
January 2025
Faculty of Pharmacy, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-003, Lisboa, Portugal.
The discovery of induced pluripotent stem cells (iPSCs) and protocols for their differentiation into various cell types have revolutionized the field of tissue engineering and regenerative medicine. Developing manufacturing guidelines for safe and GMP-compliant final products has become essential. Allogeneic iPSCs-derived cell therapies are now the preferred manufacturing alternative.
View Article and Find Full Text PDFContinued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON.
Lung
January 2025
National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, UMR 754, ERN-LUNG, Lyon, France.
Purpose: In the INBUILD trial in patients with progressive pulmonary fibrosis (PPF), nintedanib slowed the decline in forced vital capacity (FVC) versus placebo, with a safety profile characterised mainly by gastrointestinal events. INBUILD-ON, the open-label extension of INBUILD, assessed the safety of nintedanib during longer-term treatment. Data on FVC were collected.
View Article and Find Full Text PDF"Shedding the status"-a meta-analysis on the individual propensity to shed skin material in the context of forensic trace analysis.
Int J Legal Med
January 2025
Institute of Legal Medicine, University Hospital of Cologne, Melatengürtel 60-62, 50823, Cologne, Germany.
The so-called "shedder status", which can more precisely be referred to as "individual shedding propensity" (ISP), has been the subject of forensic genetic research for more than two decades. Numerous studies have been published on this topic many of which report contradictory and/or insufficiently documented results regarding the existence, influencing factors, classifications of and test methodologies for the ISP of skin material. To date, there is no scientific consensus on the best way to register and conceptualize this variable, that is essential for the assessment of DNA transfer events.
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