Medical Writing Preclinical Studies Preclinical studies

Volume 26, Issue 4 - Preclinical Studies

Preclinical studies

Abstract

Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many medical writers spend their careers in the regulated world of registered clinical trials, where there are well-defined rules, endpoints, and guidelines for writing documents. To these writers, reporting the countless methods, standards, and models used in nonclinical  and preclinical studies may seem complex and daunting. A writer may have
to learn methodological details of X-ray crystallography, drug interaction models, genetically modified species, and cell culture. Experiments in a single manuscript may involve multiple animal models, in species that may vary from apes to mice to woodchucks to zebrafish. Guidelines for reporting these methods and models may be hard to find or nonexistent, and many journals offer only sparse reporting instructions. In other words, to a medical writer accustomed to clinical trials, reporting nonclinical and preclinical research may at first seem like the Wild West.
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Articles

Preclinical studies
President’s Message
EMWA celebrates 25 years
EMWA News
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

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk