Animal Pharmacokinetic/Pharmacodynamic Studies (APPS) Reporting Guidelines

Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):483-494. doi: 10.1007/s13318-018-0498-2.


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.

Publication types

  • Guideline
  • Review

MeSH terms

  • Animals
  • Checklist
  • Consensus
  • Data Accuracy
  • Drug Administration Routes
  • Drug Administration Schedule
  • Drug Evaluation, Preclinical / methods*
  • Drug Evaluation, Preclinical / standards
  • Humans
  • Models, Animal
  • Periodicals as Topic* / standards
  • Pharmacokinetics*
  • Research Design* / standards
  • Species Specificity
  • Writing