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Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of…
The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…
My first 39 myths about English were published in The Write Stuff in a series of articles between January 2006 and January 2008. The myths are mainly drawn from claims about English made by participants at my training events on the use of English…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
Grammatical misagreement in tense
I – Present, present perfect
Introduction
Each of the sections of a journal article contains anticipated conceptual components, which can be expressed by a specific verb tense for the perspective of time and the d…
In this article, the authors outline the universal right to health, healthcare, and language access in healthcare, with a focus on policies and practices in the European Union and the United States. The authors spotlight contrasting views on whether…
NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…
In addition to subject-verb misagreement in grammatical number, a misagreement in number is common between a subject and other sentence constituents, which appears in the experimental and contextual sections of a journal article.
Paragraph lengthiness and complexity cause a continuity inexplicity (discontinuity), which can be lessened by using forecasting and backcasting markers of the information pattern. Thus, omission of such continuity markers (e.g., a subheading)…
Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…
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