Quality by Design for Biopharmaceuticals
Principles and Case Studies
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Beschreibung
The concepts, applications, and practical issues of Quality byDesign
Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process.
Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation.
In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as:
* The understanding and development of the product's criticalquality attributes (CQA)
* Development of the design space for a manufacturingprocess
* How to employ QbD to design a formulation process
* Raw material analysis and control strategy for QbD
* Process Analytical Technology (PAT) and how it relates toQbD
* Relevant PAT tools and applications for the pharmaceuticalindustry
* The uses of risk assessment and management in QbD
* Filing QbD information in regulatory documents
* The application of multivariate data analysis (MVDA) toQbD
Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.
Autor*in
Anurag S. Rathore
Themen in »Quality by Design for Biopharmaceuticals«
Biopharmazie Biotechnologie i. d. Chemie Biotechnology Chemie Chemistry Drug Discovery & Development Pharmaceutical & Medicinal Chemistry Pharmazeutische Industrie Pharmazeutische u. Medizinische Chemie Wirkstoffforschung u. -entwicklung