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.
The statistical design of experiments is an essential ingredient of successful product development and improvement, and provides an efficient and scientific approach to obtaining meaningful information. In contrast to traditional vary one-factor-at-a-time (OFAT) experimentation, variables are changed together, permitting evaluation of interactions. Standard texts give details about the construction of specific test plans, such full and fractional factorial, and response surface designs, and the analysis of the resulting data. This article gives a brief overview. The focus here is on the fundamental elements of experimental design: defining the purpose and scope of the experiment, differentiating between alternative types of experimental variables, understanding the underlying environment and constraints, and conducting stage-wise experimentation. Brief discussions dealing with the statistical analysis tools, multiple response variables, and some historical background are also provided.
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.)
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.
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.
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.