COLUMBUS, Ohio -- Drug companies may evaluate new generic drugs more thoroughly than ever before, with software developed at Ohio State University.
Drug companies must prove that the generic form of a drug functions like the original before they can receive approval from the Food and Drug Administration (FDA), explained Jean Powers, professor emeritus of statistics and veterinary clinical sciences at Ohio State.
Powers and her colleagues formulated a new, improved statistical method for comparing drugs, and Edward Herderick, manager of the Biomedical Engineering Computer Center at Ohio State, wrote the software. The Ohio State software
compares sets of curves that chart drug characteristics, and takes into account all the data relating to a particular drug function.
"The FDA already has an excellent procedure for assuring that the generic drug matches the original, but we believe our procedure represents a potential improvement," she said. She added that the same procedures she, Herderick, and their colleagues developed could be adapted to compare any two sets of curves.
Powers and Herderick collaborated with Robert Bartoszynski, a
former professor of statistics at Ohio State who died in 1998, and
Joseph A. Pultz, Bartoszynski's former graduate student, who is
now a statistician at DuPont Pharmaceuticals. A description of the
Contact: Jean Powers
Ohio State University