COMPUTERS HAVE BECOME MAJOR TOOLS IN SCIENCE AND BUSINESS.

COMPUTERS HAVE BECOME MAJOR TOOLS IN SCIENCE AND BUSINESS. THERE HAS BEEN EVOLUTION IN THE WAY IN WHICH COMPUTERS ARE USED; FROM INTEGRAL TABLE CALCULATION TO EXPERT SYSTEMS AND FROM PAYROLL PRODUCTION TO SIMULATION OF BUSINESS ACTIVITIES. ONE CHALLENGE REMAINING IS THE GENERATION OF SYSTEMS TO ASSIST IN MANAGEMENT. A PRIMARY INDICATOR OF BUSINESS SUCCESS IS THE CAPABILITY TO ASSESS THE INFORMATION AVAILABLE ABOUT RESOURCES AND PROCESSES TO MAXIMIZE THEIR UTILITY. OUR OBJECTIVE IS TO ENHANCE THE MANAGEMENT OF THE PROCESS FOR PRODUCING AND DISTRIBUTING INVESTIGATIONAL DOSAGE FORMS OF PHARMACEUTICAL PRODUCTS IN SUPPORT OF CLINICAL PROGRAMS OF THE DCT, TO ASSURE TIMELY AVAILABILITY OF THE PRODUCTS TO RESEARCHERS, ALONG WITH COMPLETE AND CORRECT INFORMATION ABOUT THE PRODUCTS. THE PHASE I STUDY WILL CODIFY THE PARAMETERS FOR TRACKING PHARMACEUTICAL PRODUCTION AND CONTROL. IT WILL SPECIFY DATA SOURCES, METHODS OF CAPTURE, VALIDATION AND VERIFICATION, AND INDICATE DELIVERY SYSTEM REQUIREMENTS. THE RESULTS OF PHASE I WILL BE A SOFTWARE SPECIFICATION THAT CAN BE REDUCED TO PROGRAMS IN PHASE II. THE ACTIVITIES TO BE PERFORMED ARE THE CURRENT STATE-OF-THE-ART OF COMPUTER SCIENCE. PHARMACEUTICAL PRODUCT EXPERTS WILL BE INVOLVED FROM THE INCEPTION OF THE PROGRAM TO ASSURE AN ACCEPTABLE DESIGN. SUCH AN EFFICIENT, IMPLEMENTABLE SYSTEM, OF DEMONSTRABLE UTILITY TO THE PHARMACEUTICAL INDUSTRY, MAY WELL BE COMMERCIALLY VIABLE.