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Activity Number:
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383
- Experimental Design Applications in the Pharmaceutical Industry
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Type:
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Invited
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Date/Time:
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Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Physical and Engineering Sciences
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Abstract #300149
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Presentation
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Title:
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Overview of DoEs and Applications in the Pharmaceutical Industry
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Author(s):
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Jyh-Ming Shoung* and Dwaine Banton and Areti Manola
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Companies:
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Janssen R&D and Janssen R&D and Janssen R&D
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Keywords:
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Abstract:
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Designs and design principles first developed by Fisher in the first half of the 20th century have had a profound impact on the collection and interpretation of scientific data. In the pharmaceutical industry, statistical designs are indispensable for the comprehensive study of analytical methodologies during product development and manufacturing to maintain and improve quality. Notions of randomization, local control and orthogonalization are powerful concepts which not only confer statistical validity to the data analysis but also provide a strong basis for claims of causality and inference. Factorial designs and various blocking designs such as split plots have been used extensively in the pharmaceutical industry. Most recently, design space construction – an experimental region describing conformance with a prespecified risk tolerance level – has been developed in a Bayesian framework built on the foundation of an appropriate design. This talk will survey examples of classical design applications and conclude with an example of design space construction.
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Authors who are presenting talks have a * after their name.
