Knowledge-Based Assistance for the Development of Drugs

• Authors: Jürgen Frank;Birgit Rupprecht;Veit Schmelmer
• Venue: IEEE Expert: Intelligent Systems and Their Applications
• Year: 1997

The knowledge-based system GSH provides assistance for one phase of the development process of a drug. It is designed to be used and maintained by pharmacists in daily routine work. The system can save development time, preserve expert knowledge, and aid the teaching of the galenical development of drugs. Developing a new drug product is a time-consuming and costly affair. From the chemical synthesis of a new substance to the entrance of the product into the market, the process typically takes 12 years and costs $400 million. But, because patent rights last only 20 years, drug developers must cover the lion's share of the cost of developing their products within eight years.So, as these numbers show, it is highly desirable to reduce R&D costs and save time during the development process. Also, extensive drug quality and safety standards sharply increase documentation efforts-for example, for justifying a drug's composition. Finally, the rapid increase of expert knowledge that must be incorporated into the process, but that is not readily available or easily accessible, aggravates the situation.This article describes the development of the Galenical Development System Heidelberg (GSH), which aims at giving knowledge-based assistance in one phase of the pharmaceutical development process-namely, the galenical routine development of dosage forms. Galenical development deals with the development of a recipe for a certain drug and its manufacturing technology. The project to develop such as system began in 1990 and is directed by Herbert Stricker, head of the Department of Pharmaceutical Technology and Biopharmaceutics at the University of Heidelberg. It runs in cooperation with the university's Department of Medical Informatics. The GSH system can save pharmaceutical companies considerable time, preserves expert knowledge, and is easy to use for people who are not experts in AI. In addition, the GSH can be used as a training tool for disseminating galenical expertise.