To facilitate an in-depth process understanding, and offer opportunities for developing control strategies to ensure product quality, a combination of experimental design, optimization and multivariate techniques was integrated into the process development of a drug product. A process DOE was used to evaluate effects of the design factors on manufacturability and product design and development 5th edition pdf product CQAs, and establish design space to ensure desired CQAs.
The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. The integrated multivariate approach exemplifies application of QbD principles and tools to drug product and process development. Check if you have access through your login credentials or your institution. Sorry, preview is currently unavailable.
You can download the paper by clicking the button above. Enter the email address you signed up with and we’ll email you a reset link. This domain is established to be used for illustrative examples in documents. Oracle Technology Network is the ultimate, complete, and authoritative source of technical information and learning about Java. Manage your account and access personalized content. Access your cloud dashboard, manage orders, and more.
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