Animal pharmacokinetic/pharmacodynamic studies are commonly used to provide meaningful preclinical information that can be utilized by the scientific community to conduct first-in-human studies. Poor presentation and interpretation of the data limit study reproducibility, and may result in rejection when the study is submitted to a journal, leading to loss of time and resources at multiple levels. In addition, inconsistencies in reporting the results of animal studies may limit the ability to extrapolate the experimental findings to humans. A few guidelines have been published to make the reporting of animal studies consistent; however, strict implementation of these guidelines by authors, reviewers, and journal editors is still lacking. In an attempt to make the reporting of animal pharmacokinetic/pharmacodynamic studies consistent and improve the standard of reporting, this article provides guidelines that can be followed when submitting such studies to a journal. A detailed checklist, based on these guidelines, has been developed that can be used by the authors, reviewers, and editors to check if the required information is included in the manuscript. These guidelines can also be used for designing and performing such studies.
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Conflict of interest
Jasbir Singh is the Editor-in-Chief of European Journal of Drug Metabolism and Pharmacokinetics and a salaried employee of Adis International Limited. He has no other conflicts of interest to declare. Fawzy Elbarbry, Ke Lan, and Tomasz Grabowski have no conflicts of interest to declare. The Editor in Chief of the European Journal of Drug Metabolism and Pharmacokinetics was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.
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Singh, J., Elbarbry, F., Lan, K. et al. Animal Pharmacokinetic/Pharmacodynamic Studies (APPS) Reporting Guidelines. Eur J Drug Metab Pharmacokinet 43, 483–494 (2018). https://doi.org/10.1007/s13318-018-0498-2