title: Addressing the Challenge of Developing a Physiologically Relevant Dissolution Test for Regulatory Purposes.
abstract: The challenge of developing a physiologically relevant dissolution test to satisfy regulatory agencies has pushed drug manufacturers to engage in "design of experiment" method development, which helps manufacturers address variability, dissolution medium, and surfactant use-all of which will influence dissolution.
authors.affiliation: Dissolution Technologies, Inc. Hockessin, Delaware ,DE, United States.
authors.forename: Vivian
authors.initials: V
authors.lastname: Gray
mesh_terms: D002626:Chemistry, Pharmaceutical; D017277:Drug Approval; D016503:Drug Delivery Systems; D006801:Humans; D010330:Patents as Topic; D004364:Pharmaceutical Preparations / Q000592:standards*; D012995:Solubility
chemical_list: D004364:Pharmaceutical Preparations
keywords: Dissolution; FDA guidances; design of experiments; f2; method development; variability