Pharmaceutical Regulatory Affairs: Open Access

Madoka Takeuchi

Publications

• Review Article
  Application of Longitudinal Analysis for Regulatory Science
  Author(s): Madoka Takeuchi and Masahiro TakeuchiMadoka Takeuchi and Masahiro Takeuchi
  
  The standard primary analysis in a clinical trial is the change from baseline analysis, failing to use all information and multiple measurements collected for each individual at various timepoints. Change from baseline analysis fails to observe the trend of the outcome, however, most decision-making in regulatory science is based on the single p-value from the change from baseline analysis. There are many possible longitudinal analysis models, utilizing repeated measurements, with the random effects model, otherwise known as the Laird-Ware model, being the most powerful and efficient model under certain assumptions. A semi-parametric approach is the Generalized Estimating Equation2. Although the longitudinal models may result in more.. Read More»
  DOI: 10.4172/2167-7689.1000127

  Abstract PDF