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OLINDA/EXM Radiation Dose Assessment Software Application (FDA Approved)
The OLINDA/EXM® personal com- puter code performs dose calculations and kinetic modeling for radiopharmaceuticals (OLINDA/EXM stands for Organ Level INternal Dose Assessment/EXponential Modeling). OLINDA® calculates radiation doses to different organs of the body from systemically administered radiopharmaceuticals and performs regression analysis on user-supplied biokinetic data to support such calculations for nuclear medicine drugs.
These calculations are used to perform risk/ benefit evaluations of the use of such pharmaceuticals in diagnostic and therapeutic applications in nuclear medicine. The technology employs a number of stan- dard body models for adults, children, pregnant women and others, that are widely accepted and used in the internal dose community. The calculations are useful to pharmaceutical industry developers, nuclear medicine professionals, educators, regulators, researchers and others who study the accepted radiation doses that should be delivered when radioactive drugs are given to patients or research subjects.
The OLINDA/EXM technology was developed by Dr. Michael Stabin, of Vanderbilt University, and Drs. Rich- ard Sparks and Eric Crowe, of CDE Dosimetry Services, Inc. The OLINDA code was written by Dr. Stabin. It is based on the MIRDOSE 3.0 and 3.1 codes (predecessors of the OLINDA code) developed by Dr. Stabin while he was at the Oak Ridge Associated Universities. MIRDOSE 3.0 and 3.1 were widely used in both the radiopharmaceutical industry and the research community for internal dose calculations for radiopharmaceuticals. They were also used by thousands of medical, safety and regulatory professionals for a number of years. OLINDA employs essentially the same calculational algorithms as MIRDOSE, with some updates that include:
• Nearly 600 new radionuclides (including alpha emitters)
• New organ phantoms
• A revised and improved bone model
• The ability to modify organ masses to patient-specific values
The EXM code, written by Dr. Sparks and Dr. Crowe, performs kinetic analysis of biokinetic data gathered in animals or humans, for input into the dose calculation algorithms.
OLINDA/EXM HAS BEEN GRANTED A 501(K) EXEMPTION BY THE U.S. FOOD AND DRUG ADMINISTRATION AS A SOFTWARE DEVICE.Potential Market Size
This technology is used by nuclear medicine researchers, physicians, regulators, educators and others who study internal dose calculations in nuclear medicine applications. Nuclear medicine equipment manufacturers may include standardized dose calculational software codes on their system workstations.
EXAMPLES OF POTENTIAL APPLICATIONS:
• Development of standardized dose calculations for potential new pharmaceuticals – When data from animal or human studies is gathered to establish the radiation dosimetry for a new radiolabeled compound, it is important for the calculations to be performed using standard and accepted methods and models. Doses calculated using OLINDA/ EXM are ideal for inclusion as package inserts supplied with new radiopharmaceuticals. These calculations are also valuable for use in published scientific literature describing radiop- harmaceutical use and safety.
• Medical subject dose analysis – Individual dose estimates can be derived for patients or volunteers who receive radiopharmaceuticals during clinical trials. Patient-specific adjustments to the standard doses provided from the models are made using known subject organ masses.
• Regulatory review – Dose estimates from different clinical trials can be directly compared and quickly understood if they are derived using the standard models and methods employed in OLINDA/EXM.
• Teaching – OLINDA/EXM permits the rapid development of dose calculations and easy modification of input assumptions so that elements of dose calculational methods can be easily understood and taught.
OLINDA/EXM® will run on standard Windows-2000 or Windows-XP based personal computers. A detailed instruction manual including implementation tests is supplied with the software. The implementation tests describe a series of sample problems that can be run to ensure the correct installation of the software. Active customer support is also provided via phone, email, regular mail or fax.
Inventors:Michael StabinRichard Sparks