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Design of Experiments for Pharmaceutical Formulation Development

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Abstract:

Design of experiments (DOE) is a useful tool for determining specific factors affecting defect levels in a product.During the 1920s, a British statistician named Ronald Fisher put the finishing touches on a method for making breakthrough discoveries. Some 70 years later, Fisher's method, now known as design of experiments, has become a powerful software tool for engineers and researchers. But why did it take engineers so long to begin using DOE for innovative problem solving? After all, they were ignoring a technique that would have produced successes similar to the following modern-day examples: John Deere Engine Works in Waterloo , Iowa , uses DOE software to improve the adhesion of its highly identifiable green paint onto aluminum. In the process, the company has discovered how to eliminate an expensive chromate-conversion procedure. Savings: $500,000 annually. Ski manufacturer K2 Corp. in Vashon, Washington , is hampered by a new ski's complex design that produces a 30-percent higher scrap rate. DOE finds the reason and the solution. Savings: Press downtime tumbles from 250 labor-hours per week to a mere 2.5.

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