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Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

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…

Good Writing Practice - Volume 30, Issue

Introduction In this regular feature, the misagreement in tense is extended from present and present perfect tense (discussed in the previous edition of MEW) to an analysis of the frequently used present participle (of the participial phrase) and…

Good Writing Practice - Volume 31, Issue

The present participle using and the past participle based on, both traditionally adjectivals, ostensibly misfunction without a noun to modify (a modifee). The frequency of their usage and misusage in research writing justifies a separate article…

Introducing EMWA’s new AI Working Group - Volume 32, Issue

Artificial Intelligence (AI) is a broad umbrella term that refers to the use of computer algorithms to perform tasks that typically require human-like intelligence, such as reasoning, learning, decision-making, and perception. The new EMWA AI…

Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice - Volume 30, Issue

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…

Pharmacovigilance for vaccines and immunotherapies - Volume 27, Issue

Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…

Journal Watch - Volume 21, Issue

Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…

To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting - Volume 32, Issue

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…

In vitro plants: How to open a jar containing bioactive phytochemicals - Volume 32, Issue

Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…

Writing narrative style literature reviews - Volume 24, Issue

Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…

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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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