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Résultats de la recherche - 137 results
Microbial quality analysis of falsified medicines seized by controling agencies
or biological risk. These findings plead for a continuing vigilance of the international and national regulatory agencies and law enforcement agencies and to informing and warn the patients of the ...
Innovative non-animal based testing platform to detect chemical-induced cardiotoxicity- A roadmap for regulatory uptake
Publication Type: Scientific poster, presentation or proceeding Authors: Sivakumar Murugadoss; Alexandra Schaffert; Ronette Gehring; Tom Roos; Nunzia Linzalone; Gabriele Donzelli; Martin Paparella; Birgit Mertens Source: 57th Congress of the European Soci ...
Innovative non-animal based testing platform to detect chemical-induced cardiotoxicity- A roadmap for regulatory uptake
Publication Type: Scientific poster, presentation or proceeding Authors: Sivakumar Murugadoss; Alexandra Schaffert; Ronette Gehring; Tom Roos; Nunzia Linzalone; Gabriele Donzelli; Martin Paparella; Birgit Mertens Source: Joint 3R Symposium, Brussels, Belg ...
Oncolytic Viruses: An Inventory of Shedding Data from Clinical Trials and Elements for the Environmental Risk Assessment.
assessment of subject safety, quality and efficacy aspects of medicinal products for human use, genetically modified viruses are also governed by EU regulatory frameworks requiring an environmental risk ...
A roadmap for regulatory implementation of in vitro models for evaluation of vaccine efficacy
Regulatory roadmap Vaccine Efficacy Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et ...
A Systematic Review on Pollutant Induced Cardiotoxicity: Providing a Toxicological Foundation for NAM Development and Regulatory Acceptance
Publication Type: Scientific poster, presentation or proceeding Authors: T. Roos; C. Leenaars; A. Schaffert; M. Paparella; S. Murugadoss; Birgit Mertens; N. Linzalone; G. Donzelli; M. Ritskes-Hoitinga; R. Gehring Source: 12th World Congress on Alternative ...
Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies
Illicit PDE-5 inhibitors are frequently encountered by regulatory agencies. Self-medicating with substandard and falsified (SF) PDE-5 inhibitors could be dangerous as they are likely taken without any ...
Cardiotoxicity of chemicals: Current regulatory guidelines, knowledge gaps, and needs.
Publication Type: Peer reviewed scientific article Authors: Alexandra Schaffert; Sivakumar Murugadoss *; Birgit Mertens *; Martin Paparella Source: Volume 40, Issue 2 (2023) Keywords: Cardiotoxicity environmental exposure Hazardous Substances Humans Healt ...
Cardiotoxicity of chemicals: Current regulatory guidelines, knowledge gaps, and needs.
Publication Type: Peer reviewed scientific article Authors: Schaffert, Alexandra; Murugadoss, Sivakumar; Mertens, Birgit; Paparella, Martin Source: ALTEX, Volume 40, Issue 2 (2023) Keywords: Cardiotoxicity environmental exposure Hazardous Substances Human ...
Regulatory expectations on the use of vaccine reference standards for maintaining product quality.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Maintaining the Quality of Vaccines through the Use of Standards: Current Challenges and Future Opportunities, IABS, Issue IABS, Ottawa, Canada (2023) Abstract: ...