Medical Writing Preclinical Studies An introduction to little-known aspects of nonclinical regulatory writing

Volume 26, Issue 4 - Preclinical Studies

An introduction to little-known aspects of nonclinical regulatory writing


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 nonclinical writers is growing due to the increasing complexity of drug development and regulatory requirements. Yet dedicated resources for nonclinical writers are scarce, and nonclinical health authority guidelines provide little guidance on regulatory writing. In this article, we present an overview of nonclinical development from the perspective of a regulatory writer, highlighting aspects that cannot be discerned from the guidelines. We then give an overview of nonclinical documentation and further describe the distinct challenges of nonclinical regulatory writing and how it differs from clinical regulatory writing. Finally, we discuss key attributes of nonclinical writers.
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Preclinical studies
President’s Message
EMWA celebrates 25 years
Preclinical research in drug development
An introduction to little-known aspects of nonclinical regulatory writing
Reporting of preclinical research: What do we get told – when and how?
Mind the gap – towards complete and transparent reporting of animal research
The reproducibility crisis in preclinical research – lessons to learn from clinical research
Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards
How to survive Brexit as an independent medical writer
Creation of a patient-centric patient lay summary in the local language
Six communication rules for scientific presentations and writing
So, you want to be a medical journalist?
News from the EMA
Profile: An interview with Steven Walker
Getting Your Foot in the Door
In the Bookstores
Journal Watch
The Webscout
Good Writing Practice
Medical Communications
Out on Our Own


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