Medical Writing Preclinical Studies An introduction to little-known aspects of nonclinical regulatory writing
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Volume 26, Issue 4 - Preclinical Studies

An introduction to little-known aspects of nonclinical regulatory writing

Abstract

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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