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Uncertainty is an unavoidable problem when analysing health technology assessment results, which can make decision making difficult. Whilst we have ways of presenting uncertainty for individual outcomes in a systematic review, we do not have a…
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…
Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…
Writing for lay audiences requires language that is understandable by readers without expertise in the subject matter at hand. This means carefully selecting, organising, wording, and supporting content, focusing on conveying relevant points in a…
Greetings, readers.In this issue of OOOO, we start off with an important question – how do I prevent the risk of working too much? An apt question as we approach the end of the year, finishing up our projects and settling in to enjoy the holiday…
Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…
Critical thinking is necessary to edit a scientific article. However, in addition to questions about the language, we can also question the assumptions, documentation, and implications of the research, in a process I call “analytical editing.” A…
For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…
Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
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.
Medical Writing is listed in the following indexes:
Editor-in-Chief
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Managing Editor
Victoria White
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
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Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Freelancing
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Regulatory Matters
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Teaching Medical Writing
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
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Chris Monk