title: The Role of Physiologically Based Oral Absorption Modelling in Formulation Development Under a Quality by Design Paradigm.
abstract: Within the last decade, Quality by Design (QbD) has been getting increased attention in its implementation in the development of pharmaceutical drug products. Understanding of the impact of formulation composition and process on clinical performance is a centerpiece of QbD. Physiologically based pharmacokinetic modeling incorporating biorelevant dissolution and a systems parameter approach to gastrointestinal absorption has been gaining increased traction in the pharmaceutical industry as an important tool to guide early formulation development. Extension of the models to support QbD appears the next logical step. This commentary discusses the current status of use of these models in the pharmaceutical industry and the opportunities these models can offer in ensuring drug product quality moving forward, including the development of clinically relevant specifications.
authors.affiliation: Biopharmaceutics and Specialty Dosage Forms, Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania 19486-0004. Electronic address: filippos_kesisoglou@merck.com.
authors.forename: Filippos
authors.initials: F
authors.lastname: Kesisoglou
mesh_terms: D000284:Administration, Oral; D004339:Drug Compounding; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects / Q000502:physiology*; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000378:metabolism* / Q000592:standards; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations
keywords: Quality by Design; absorption; bioequivalence; dissolution; formulation; intestinal absorption; pharmacokinetics; physiologically based pharmacokinetic modeling