We have located links that may give you full text access.
Journal Article
Review
Roadmap for implementation of quality by design (QbD) for biotechnology products.
Trends in Biotechnology 2009 September
Quality by design (QbD) has been receiving a lot of attention in the pharmaceutical community of late. Successful QbD implementation requires a thorough understanding of the relationship between the critical quality attributes (CQAs) and the clinical properties of the product, the relationship between the process and CQAs and the variability in raw materials. This article presents a roadmap for successful QbD implementation for therapeutic biotechnology products. The approach presented here is aligned with existing regulatory guidance documents. Key developments are reviewed and case studies are used to illustrate these concepts. It is concluded that although several QbD concepts are being practiced by the biotechnology industry, successful dialogue and partnership between the industry and its regulators will be the key to successful QbD implementation.
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app