SOFTWARE DEVELOPMENT FOR DESIGN OF KINETIC EXPERIMENTS
DESCRIPTION (Adapted from the applicant's abstract): Kinetica is a computer- based mathematical modeling environment for researchers in tracer kinetics, pharmacokinetics, enzyme kinetics, physiology, and other biological and nonbiological fields. Since its beginning, Kinetica has been designed to eventually bring together a range of modeling tools, including the design of optimal experiments, into a consistent, user-friendly, and intuitive program. The goal of the current research is to begin the specification, development, and implementation of experimental design tools to be incorporated into Kinetica. Specifically, the applicants will develop a prototype interface with which the user will define the experimental conditions to optimize, invoke constraints, select a design goal, initiate an analysis, and display and interpret results. Design goals available to the user will include parameter estimation, prediction, model discrimination, and any other goal identified during Phase I. Considerable effort will go into exhaustively considering all combinations of available experimental features, then identifying and prioritizing those for which the required theory or computational tools are not available. Theory will be developed as needed and in Phase II, the numerical methods with highest priorities will be implemented, producing a fully functional program. Creation and usability testing of the interface and rigorous definition of the computational requirements will demonstrate the feasibility of the software. $ = TOTAL AWARD AMTS & NOT LIMITED TO PORTION OF PROJECT RELATED TO SUBJECT OF SEARCH SUBPROJECT $ = TOTAL AWARD AMOUNT DIVIDED BY NUMBER OF SUBPROJECTS SOURCE: CRISP FORMAT F FY 97 LAST UPDATE 04-07-98 1QUERY 1536 ID SEARCH 06/01/98 PAGE 519 --PROJECT NUMBER......1 R43 RR11639-01 INVESTIGATOR NAME/ADDRESS FY 97 MACKINTOSH, DOUGLAS R IRG/INTRAMURAL UNIT..ZRG7 GCPA, INC AWARD AMOUNT......... $99,885 12500 FAIR LAKES CIRCLE FAIRFAX, VA 22033 PERFORMING ORGANIZATION: GOOD CLINICAL PRACTICES AUDITING, INC. TITLE CAUSAL ANALYSIS OF AES--PATTERN RECOGNITION SOFTWARE ABSTRACT: DESCRIPTION (Adapted from applicant's abstract): Determining if an adverse event is an adverse drug reaction is a difficult process made more complicated in clinical trials that address complex chronic diseases such as immune system compromise. Patients on study typically experience many adverse events, some serious, over the course of drug treatment and after treatment ceases. Previous attempts at facilitating safety analysis have concentrated on simple scoring mechanisms, probability algorithms including a Bayesian approach, recently automated, and global clinical impressions. These analytic methods work best on simple infections and skin diseases, but cannot address complex chronic diseases. In Phase I, software will be developed to analyze clinical trials safety data for chronic diseases. A prototype will be built for multiple sclerosis using actual Phase III trial data. The software will 1) facilitate linkages or pattern recognition among events, between events and medication administration, and between events and lab test results 2) cluster events temporally and by body system and 3) facilitate comparisons between placebo and study drug safety profiles. At the end of Phase I, a panel of clinicians, including medical monitors who prepare safety profiles for clinical trials results, will evaluate the software for ease of use, robustness, and regulatory compliance. In Phase II, the software will be refined and a comparative trial of its analytic power will be conducted on a different chronic disease data set. The goal of the project is to produce software that can be used by clinical researchers, drug and device manufacturers, the FDA, and regulatory agencies in the European Union in determining the relative safety of a new drug. $ = TOTAL AWARD AMTS & NOT LIMITED TO PORTION OF PROJECT RELATED TO SUBJECT OF SEARCH SUBPROJECT $ = TOTAL AWARD AMOUNT DIVIDED BY NUMBER OF SUBPROJECTS SOURCE: CRISP FORMAT F FY 97 LAST UPDATE 04-07-98 1QUERY 1536 ID SEARCH 06/01/98 PAGE 520 --PROJECT NUMBER......1 R43 RR11671-01A1 INVESTIGATOR NAME/ADDRESS FY 97 WU, JAY Y IRG/INTRAMURAL UNIT..ZRG7 CRYOMAGNETICS, INC AWARD AMOUNT......... $100,000 1006 ALVIN WEINBERG DR OAK RIDGE, TN 37830 PERFORMING ORGANIZATION: CRYOMAGNETICS, INC. TITLE 800 MHZ HIGH RESOLUTION NMR MAGNET ABSTRACT: DESCRIPTION: This project is aimed at developing a 800 MHz high resolution NMR magnet with internal tin superconducting wires. This magnet will be ideal for micro imaging and in vivo spectroscopy as well as biological solid state NMR spectroscopy. Replacing bronze-processed Nb3Sn wire by internal tin wire, high field NMR system cost will be reduced significantly. Phase I research objective is to solve engineering problems related to construction of a 800 MHz high resolution NMR magnet. To achieve the objective, Cryomagnetics, Inc. proposes the technical approach: developing model coils to experimentally determine the internal tin wire stability in persistent mode operation at 2.2K temperature. At the end of Phase I, an engineering design of a 800 Mhz high resolution NMR magnet will be completed, and this design will be the starting point for Phase II research: develop a full scale 800 MHz NMR magnet with internal tin wires.
Small Business Information at Submission:
Principal Investigator:Beltz, william f
3030 REYNARD WAY San Diego, CA 92103
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