Medical Writing Preclinical Studies Preclinical research in drug development

Volume 26, Issue 4 - Preclinical Studies

Preclinical research in drug development


The process of developing a novel drug is time consuming and costly. To increase the chances of successfully completing a clinical trial leading to the approval of a new drug, the choice of appropriate preclinical models is of utmost importance. Identifying a safe, potent, and efficacious drug requires thorough preclinical testing, which evaluates aspects of pharmacodynamics, pharmacokinetics, and toxicology in in vitro and in vivo settings.  Nevertheless, merely a small fraction of investigational new drugs tested in clinical trials after passing preclinical evaluation eventually lead to a marketed product. Hence, there is a need for optimising current standard preclinical approaches to better mimic the complexity of human disease mechanisms.
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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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