title: It's time.
abstract: Statistical inference involves taking the results of models and knowledge about probability to make decisions about the relationship in question. This commentary explains the usefulness of statistical inference to the drug development process, as well as some common pitfalls. It also examines reasons why statistical inference does not seem to be fully integrated into pharmacometric modeling. An example is shown that demonstrates the inferential advantages of mechanistic models. Both statisticians and pharmacometricians ought to take note of these advantages and integrate their efforts in order to maximize the decision-making potential of clinical research.
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Drop Code 2233, Indianapolis, IN 46285, USA. b.smith@lilly.com
authors.forename: Brian P
authors.initials: BP
authors.lastname: Smith
mesh_terms: D000704:Analysis of Variance; D016001:Confidence Intervals; D008954:Models, Biological; D010601:Pharmacology, Clinical / Q000706:statistics & numerical data*