title: Utilization of population pharmacokinetics in drug development and provision of the results to healthcare professionals .
abstract: OBJECTIVE
  The aim of this research is to understand the level of utilization of population pharmacokinetics (PPK) in drug development in the United States of America (US) and Japan, and to discuss what kind of PPK information should be provided to healthcare professionals.
  
  
  METHODS
  Information on PPK was identified on the label, package insert, and pharmaceutical evaluation report disclosed by the US Food and Drug Administration and the Pharmaceutical Medical Devices Agency of Japan for new molecular entities approved between January 2012 and December 2015.
  
  
  RESULTS
  Between January 2012 and December 2015, 152 new molecular entities were approved in the US and 176 in Japan. The proportion of documents using PPK data in the US increased each year, but in Japan the proportion plateaued. The proportion of US labels and that of Japanese package inserts containing PPK parameters was 37.2% (32/86) and 41.9% (13/31), respectively.
  
  
  CONCLUSIONS
  PPK use in drug development in the US is increasing each year, there is no similar increase occurring in Japan. We expect that the use of pharmacometrics, including PPK and PPK/pharmacodynamics (PD), will become more common in drug development, and that by sharing the PPK model obtained from clinical trial promptly within medical practice they can be effectively utilized in individualized drug administration plans. .
authors.forename: Megumi
authors.initials: M
authors.lastname: Watanabe-Uchida
authors.forename: Mamoru
authors.initials: M
authors.lastname: Narukawa
mesh_terms: D017277:Drug Approval / Q000706:statistics & numerical data; D055808:Drug Discovery / Q000379:methods* / Q000639:trends; D004348:Drug Labeling / Q000592:standards / Q000706:statistics & numerical data; D017408:Guidelines as Topic; D006801:Humans; D007564:Japan; D004364:Pharmaceutical Preparations / Q000097:blood*; D010599:Pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations