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Getting started writing a manuscript – or any other document for that matter – can be difficult. Manuscripts are large projects, sometimes taking hundreds of hours and many months to complete. Faced with a blank page or screen, one might be tempted…
Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…
To the Editor – I read the recent article on the fourth EMWA freelance business survey1 with great interest and some considerable concern. When freelance writers express an interest in working with Rx Communications, one of the first things we ask…
A complete re-evaluation of your career path can be a daunting task. By identifying your own key skills, a proactive approach can be taken. Talking to varied companies and people in the field and trying out different writing styles can help to find…
The history of immunotherapy to treat cancer began in 1891 when the American surgeon William Coley performed intra-tumoural injections with inactivated bacteria in patients with advanced sarcoma, in an attempt to stimulate anti-tumour immunity.…
This issue of Out on Our Own is jam-packed with essential tips for any new freelancers or those tempted to become freelancers. Taking that step to becoming a freelancer isn’t only about finding clients, there’s so much more involved that perhaps…
Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…
EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…
Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
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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