title: [Quantitative Decision Making in Drug Development: Pharmacometrics].
abstract: According to the US Food and Drug Administration, pharmacometrics is an emerging science that quantifies drugs, diseases, and trial information to aid efficient drug development and/or regulatory decisions. Quantitative decision making occurs at all stages of drug development. In general, patient-level data are not made available to competitors. However, summary-level data are available. Model-based meta-analysis (MBMA) is a powerful tool for decision making which identifies the candidate position in the market. The limitation of MBMA is the heterogeneity of the treatment effect. In the near future, MBMA application is expected at every stage of drug development.
authors.affiliation: Pfizer Japan Inc., Clinical Pharmacology.
authors.forename: Akiyuki
authors.initials: A
authors.lastname: Suzuki
mesh_terms: D000066491:Clinical Decision-Making; D055808:Drug Discovery; D006801:Humans; D015201:Meta-Analysis as Topic