title: Maximizing the Impact of Physiologically Based Oral Absorption Modeling and Simulation.
abstract: The challenge of bringing innovative medicines to patients in combination with intense competition within the pharmaceutical industry has induced companies to develop quality medicines more efficiently and cost-effectively. State-of-the-art approaches to advance drug development have never been so urgent. One such approach that has been gaining traction within the industry is the application of modeling and simulation. In this commentary, the benefits of physiologically based oral absorption modeling and simulation in drug development are highlighted and suggestions for maximizing its impact are provided.
authors.affiliation: Amgen Inc., Drug Product Technologies, Thousand Oaks, California 91320. Electronic address: jochung@amgen.com.
authors.forename: John I
authors.initials: JI
authors.lastname: Chung
authors.affiliation: Amgen Inc., Drug Product Technologies, Thousand Oaks, California 91320.
authors.forename: Ron C
authors.initials: RC
authors.lastname: Kelly
authors.affiliation: Amgen Inc., Pharmacokinetics and Drug Metabolism, Thousand Oaks, California 91320.
authors.forename: Jan
authors.initials: J
authors.lastname: Wahlstrom
authors.affiliation: Amgen Inc., Medical Sciences, Thousand Oaks, California 91320.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Wu
authors.affiliation: Amgen Inc., Drug Product Technologies, Thousand Oaks, California 91320.
authors.forename: Tian
authors.initials: T
authors.lastname: Wu
authors.affiliation: Amgen Inc., Drug Product Technologies, Thousand Oaks, California 91320.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alvarez-Nunez
mesh_terms: D000284:Administration, Oral; D003198:Computer Simulation; D065569:Gastrointestinal Absorption / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism*; D010829:Physiological Phenomena / Q000187:drug effects / Q000502:physiology
chemical_list: D004364:Pharmaceutical Preparations
keywords: disposition; formulation; gastrointestinal; in silico modeling; mathematical model; oral absorption; oral drug delivery; physiologically based pharmacokinetic modeling