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The study, "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects," does not recommend changes to existing regulations, but rather deals more with the science needed to determine whether food from genetically engineered crops and animals might be harmful.
Reporting emerges as a mere actor, while new dimensions of safety drivers emerge from the study: safety also comes from a value contribution focus, a decentralized safety management approach, the centrality of reporting in a safety management system and the dependency on engaged relationships.
The study safety and endpoint data were reviewed annually by an independent data and safety monitoring board.
The secondary pre-specified outcome of the study (safety) was assessed by the collection of all adverse events occurred during the study, including any significant change in haematological (including coagulation assessment), biochemical (with liver and kidney functional parameters) and immunological parameters (including CD4+, CD8+, CD3+ T cells, NK, B cells and monocytes).
The study safety review process then resulted in cessation of further activities on AZD9164.
The study safety officer reviewed all relevant safety data obtained from the study sites.
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The patient completed the core study safety monitoring until Week 52, but was not eligible to continue in the extension.
In the present study, safety will be operationalized using these two dimensions [ 63].
In the same prospective study, safety and efficacy assessments were measured 36 60 months after the first injection of Aquamid.
To design safety automated systems, the designer must study safety according to various points of view.
In both of these studies, safety is the primary outcome being measured.
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CEO of Professional Science Editing for Scientists @ prosciediting.com