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Michael Stabin, PhD, Assistant Professor of Radiology and Radiological Sciences, and colleagues at Vanderbilt University received PDA exemption (premarket notification, 510K) on June 15 for the production and distribution of software containing personal computer code designed to update the now outmoded but still much sought after MIRDOSE3.1. Called OLINDA/EXM (for Organ Level INternal Dose Assessment/BXponential Modeling), the software was developed over the course of several years as a direct result of difficulties in MIRDOSE distribution and increasing incompatibility with upgraded systems. "We are pleased to finally be able to offer this software, which extends beyond lhe limits of previous dose calculation software and adds new and useful features," said Stabin. "And we're particularly proud to have worked so successfully with the FDA, which was very responsive and helpful throughout the process."
Background
The primary purpose of the original MIRDOSE software was to perform calculations needed to obtain dose estimates for the various organs of the body once the kinetics of a radiopharmaceutical agent were established. The code's other purpose was to help standardize dose calculations in the user community through the use of recognized models and techniques for dosimetry. The MIRDOSE code series, which appeared in the mid-1980s, was designed primarily to relieve the tedium of performing repetitive manual dose calculations by hand using lookup tables. With these codes, basic dose calculations could be made in seconds instead of hours. MIRDOSEl was used only in-house at the Radiation Internal Dose Information Center (RIDIC; Oak Ridge, TN), where it was developed. The program was limited in its applications and could be run on only one type of computer. MIRDOSE2 was released in 1987 for IBM-compatible computers and included about 60 radionuclides and 6 anthropomorphic phantoms representing both children and adults (the Cristy-Eckerman series). MIRDOSE2 was widely distributed and used in the nuclear medicine community. MIRDOSE3 was released in 1994 and included more than 200 radionuclides...