Animal Pharmacokinetic/Pharmacodynamic Studies (APPS) Reporting Guidelines

Area of Science:

• Preclinical research
• Pharmacokinetics and pharmacodynamics
• Scientific reporting

Background:

• Animal pharmacokinetic/pharmacodynamic (PK/PD) studies are vital for preclinical data and first-in-human studies.
• Inconsistent reporting and interpretation of animal PK/PD data hinder reproducibility and human extrapolation.
• Existing guidelines for animal study reporting lack consistent implementation by authors, reviewers, and editors.

Framework:

• This article proposes standardized guidelines for reporting animal PK/PD studies.
• A detailed checklist is provided to ensure comprehensive reporting of essential information.
• These guidelines aim to improve the quality and consistency of PK/PD study publications.

Implementation:

• Authors can utilize the guidelines and checklist during the design and execution phases of animal PK/PD studies.
• Reviewers and editors can apply the checklist to assess the completeness and quality of submitted manuscripts.
• Consistent application is expected to reduce manuscript rejection rates and resource wastage.

Implications:

• Improved reporting standards will enhance the reliability and interpretability of preclinical PK/PD data.
• Enhanced data extrapolation from animal models to human studies is anticipated.
• The guidelines and checklist will contribute to more robust and reproducible scientific research in drug development.