Animal Pharmacokinetic/Pharmacodynamic Studies (APPS) Reporting Guidelines

抄録

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 the study reproducibility and may result in rejection when the study is submitted to a journal, leading to wastage of time and resources at multiple levels. In addition, inconsistencies in reporting 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, implementation of these guidelines by the authors, reviewers and journal editors still remains a concern. In an attempt to make the reporting of animal pharmacokinetic/pharmacodynamic studies consistent 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 that the required information is included in the manuscript. These guidelines can also be used for designing and performing such studies.