Quality by Design for Biopharmaceuticals

Lingua: inglese

Editore: John Wiley and Sons Inc, US, 2009

0470282339 / 9780470282335

Serie: Libro 2 di 6 - Wiley Series in Biotechnology and Bioengineering

Da: Rarewaves.com UK, London, Regno UnitoRarewaves.com UK

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The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA)Development of the design space for a manufacturing processHow to employ QbD to design a formulation processRaw material analysis and control strategy for QbDProcess Analytical Technology (PAT) and how it relates to QbDRelevant PAT tools and applications for the pharmaceutical industryThe uses of risk assessment and management in QbDFiling QbD information in regulatory documentsThe application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.…

Codice articolo LU-9780470282335

Titolo
Quality by Design for Biopharmaceuticals
Autore
Anurag S. Rathore
Editore
John Wiley and Sons Inc, US
Anno di pubblicazione
2009
Condizione
New
Rilegatura
Hardback
Lingua
inglese
ISBN 10
0470282339
ISBN 13
9780470282335
Peso dell'articolo
585 grammi
Serie
Libro 2 di 6: Wiley Series in Biotechnology and Bioengineering

Rarewaves.com UK

London, Regno Unito

Venditore con 5 stelle

Venditore AbeBooks dal 11 giugno 2025

Tariffe di spedizione da Regno Unito a U.S.A.

ArticoloDa 60 a 60 giorni lavorativiDa 60 a 60 giorni lavorativi
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