Volume 26, Issue 4 - Preclinical Studies
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
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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.