Case Studies and White Papers
DOE was used to determine the optimum setting conditions for three components leading to a high Hg Yield at a lower temperature.
Statistical methods are becoming increasingly important for the pharmaceutical industry. The FDA and other regulatory and standard-setting organizations are moving swiftly to establish Quality by Design (QbD) guidance relevant to the needs of pharmaceutical manufacturing. The FDA suggests the use of design of experiments (DoE) because it provides a structured, organized method for determining the relationship between factors affecting a process and the response of that process.
Using Design of Experiments to Optimize Chiral Separation
Via application of response surface methods, Wyeth Pharmaceuticals substantially increased yield of an active ingredient at more robust process conditions.
Schiff Nutrition used DOE to solve an intermittent problem with a multimineral tablet sticking inside the dies of a high-speed rotary tablet press. (To see the figures, download the manuscript from link below.)
The Dresser Waukesha development team adopted the design of experiments (DOE) approach to increase the accuracy of performance estimates and reduce the number of required tests.
This article details the role DOE in achieving Quality by Design (QbD) for the manufacture of active pharmaceutical ingredients (API). It features outputs from Design-Expert, the author's top choice for DOE software.
To accelerate their product development, Z Corporation tooled up their engineers with the knowledge and software to do statistical design of experiments (DOE). The company developed a procedure by which every factor with a reasonable chance of affecting product performance is systematically and simultaneously evaluated via these controlled experiments.
To accelerate their product development, Z Corporation tooled up their engineers with the knowledge and software to do statistical design of experiments (DOE). The company developed a procedure by which every factor with a reasonable chance of affecting product performance is systematically and simultaneously evaluated via these controlled experiments.
Aided by DOE, biochemists determined the statistically significant factors affecting the growth of an E. coli cell line in shaker flasks.
Making Use of Mixture Design to Optimize Olive Oil - A Case Study
Olive oil, an important commodity of the Mediterranean region and a main ingredient of their world-renowned diet (see sidebar), must meet stringent European guidelines to achieve the coveted status of "extra virgin." Oils made from single cultivars (a particular cultivated variety of the olive tree) will at times fall into the lower "virgin" category due to seasonal variation. Then it becomes advantageous to blend in one or more superior oils. This is a great case to become acquainted with the tools of mixture design for optimal formulation.