Current status and future perspective on preclinical pharmacokinetic and pharmacodynamic (PK/PD) analysis: Survey in Japan pharmaceutical manufacturers association (JPMA)

Abstract

Preclinical pharmacokinetic/pharmacodynamic (PK/PD) analysis is an efficient tool for the translational research and proof of mechanism/concept in animals. The questionnaire survey on the practice of preclinical PK/PD analysis was conducted in the member companies of the Japan Pharmaceutical Manufacturers Association (JPMA). According to the survey, 60% of companies conducted preclinical PK/PD analysis and its impact for drug development was different between each of the companies. The frequently analyzed therapeutic areas of preclinical PK/PD analysis were neurology, inflammation and metabolic disease, and those are different from the therapeutic area (infectious disease and oncology) in which PK/PD analysis was considered as effective by the present survey. Many companies which have used preclinical PK/PD analysis for the translation to human PK/PD and for the prediction of dose/regimen had good communication with other research & development (R&D) departments (e.g. pharmacology/clinical pharmacology). The increase in resources for preclinical PK/PD analysis including education was highly demanded. As a future perspective, the closer collaboration between pharmacokinetics scientists, pharmacologists, toxicologists and clinical pharmacologists and the increase in resources including upskilling and the comprehension of preclinical PK/PD analysis by the project team are considered to lead to efficient contributions to improve the success ratio of drug discovery and development.