| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 2484771 | Journal of Pharmaceutical Sciences | 2013 | 5 Pages |
Abstract
The application of key elements of quality by design (QbD), such as risk assessment, process analytical technology, and design space, is discussed widely as it relates to freeze-drying process design and development. However, this commentary focuses on constructing the Design and Control Space, particularly for the primary drying step of the freeze-drying process. Also, practical applications and considerations of claiming a process Design Space under the QbD paradigm have been discussed.
Keywords
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Authors
Sajal Manubhai Patel, Michael J. Pikal,