Software to make testing of new generic drugs mor...( software and the sta...)

In the article, the researchers show how the software compares dissolution curves -- graphs that map how quickly a drug is released into the body. This is one of several criteria that drug companies must address when seeking approval for a generic drug. Dissolution is an important factor for the consumer of a drug, since the drug must be released into the body before it can begin to take effect, Powers said.

"You wouldn't want to buy two different brands of aspirin and find out that one can begin to relieve your headache in half an hour and the other can't begin to relieve it for two hours," said Powers.

The procedure to compare the dissolution of two drugs is computationally intensive, Powers and Herderick explained. The current approach is for the drug company statisticians to chart the dissolution of each drug graphically, take averages of multiple graphs, and compare points along the averaged graphs to see if they match up.

With the Ohio State software, statisticians could compare all points of the graphs at once -- a much more comprehensive analysis. For instance, in a typical dissolution analysis, a statistician would examine six graphs from the original drug, and six from the generic drug, for 12 graphs total. Then he or she would combine the 12 graphs into two average graphs, and compare selected points along both.
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Contact: Jean Powers
Powers.7@osu.edu
614-292-6661
Ohio State University
13-Jun-2001