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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 increasing amount of data available together with advances in computer science are converting computers from simple tools that execute commands into self-taught, self correcting machines that make decisions. This is the beginning of the era of…
To encourage individuals and businesses to write in simpler, more readable English, private and government-backed enterprises have created a number of freely available online resources. While most relate to general English use, some are devoted to…
To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…
Automation and artificial intelligence (AI) are useful tools that are rapidly progressing in many fields within the clinical trial landscape, and their use in the production of narratives for clinical study reports is no exception. Technology and…
Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…
This article discusses the challenges and quality assurance measures implemented by the authors when translating medical reports. In particular, the authors discuss the challenges posed by acronyms, handwritten and scanned text, and desktop…
The purpose of the articles in the Good Writing Practice section is to focus on style, not on punctuation or grammar. However, apostrophes are a stumbling block for many writers and so require some discussion. Some people have simply not learned how…
The right software can save you a lot of time and make your life much easier. You can choose from a huge range of packages for different medical writing or related activities. It is worth taking a look at what other medical writers recommend to use.…
Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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