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Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…
Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…
Effective medical communication is critical for patient consent, adherence to treatment, and improved health outcomes. Visual aids, such as infographics, diagrams, and charts, have proven invaluable for enhancing comprehension, particularly of…
Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…
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…
Clinical trials are becoming more complex and the efforts to optimise drug development are rapidly evolving. This Q&A gives a short overview of the strategies Bristol Myers Squibb implements to incorporate diversity into the clinical trial…
Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…
Section Editors: Clare Chang, Zuo Yen Lee Briefing documents: Facilitating health authority interactions Author: Clare Chang Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…
A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
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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