Quality by design for biopharmaceuticals
179,00 $

Quality by design for biopharmaceuticals

ROHIN MHATRE, ANURAG S. RATHORE


Quality by design for biopharmaceuticals

ROHIN MHATRE, ANURAG S. RATHORE

179,00 $ 179,00 $
Régulier: 179,00 $
Rabais: 0,00 $ (0%)
Livre numérique non disponible
Résumé
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 process
  • 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 to QbD
  • Relevant PAT tools and applications for the pharmaceutical industry
  • The uses of risk assessment and management in QbD
  • Filing QbD information in regulatory documents
  • The 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.


Détails
Titre
Quality by design for biopharmaceuticals
Prix
179,00 $
Sujet
Format Poche
Non
Langue
Français/French
Date de publication
2011-09-20
ISBN
9780470466308
Code Interne
2174171
Numéro de produit
2174171
Format numérique
pdf
Protection
Adobe DRM
Entrepôt Numérique
NUMILOG

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