Quality Improvement and Robust Design Methods to a Pharmaceutical Research and Development

Researchers often identify robust design, based on the concept of building quality into products or processes, as one of the most important systems engineering design concepts for quality improvement and process optimization. Traditional robust design principles have often been applied to situations...

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Bibliographic Details
Published in:Mathematical Problems in Engineering 2012-01, Vol.2012 (2012), p.975-988-061
Main Authors: Cho, Byung Rae, Shin, Sangmun
Format: Article
Language:English
Subjects:
Comparative studies
Degradation
Design engineering
Design optimization
Experiments
Handles
Ingredients
Mathematical models
Maximum likelihood method
Optimization
Optimization models
Pharmaceuticals
Product quality
R&D
Research & development
Research and development
Robust design
Standard deviation
Studies
Systems engineering
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Summary:Researchers often identify robust design, based on the concept of building quality into products or processes, as one of the most important systems engineering design concepts for quality improvement and process optimization. Traditional robust design principles have often been applied to situations in which the quality characteristics of interest are typically time-insensitive. In pharmaceutical manufacturing processes, time-oriented quality characteristics, such as the degradation of a drug, are often of interest. As a result, current robust design models for quality improvement which have been studied in the literature may not be effective in finding robust design solutions. In this paper, we show how the robust design concepts can be applied to the pharmaceutical production research and development by proposing experimental and optimization models which should be able to handle the time-oriented characteristics. This is perhaps the first attempt in the robust design field. An example is given, and comparative studies are discussed for model verification.
ISSN:1024-123X
1563-5147
DOI:10.1155/2012/193246