Information Modeling for Pharmaceutical Product Development

نویسندگان

  • Chunhua Zhao
  • Leaelaf Hailemariam
  • Ankur Jain
  • Girish Joglekar
  • Venkat Venkatasubramanian
  • Kenneth Morris
  • Gintaras Reklaitis
چکیده

Development of a pharmaceutical product involves several inter-related steps with multiple decisions requiring iterative improvements. Large amounts of information, including the properties of a drug substance, interactions of materials, unit operations, equipment etc, have to be gathered and used for decision making. A systematic model of the associated information is thus needed to streamline the product development process and provide a common foundation to support the information. Following the information-centric infrastructure proposed in our earlier work, ontology has been used to model the information. The information modeled as ontology provides information in a way that can be easily used by humans and processed by machines. The information modeling process and developed ontology are discussed in detail. The benefits are demonstrated by using a case study for managing information generated from the preformulation stage of pharmaceutical product development.

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تاریخ انتشار 2006