Home » Nonfiction » Anurag S. Rathore » Quality by Design for Biopharmaceuticals

August 24 , 2008

Quality by Design for Biopharmaceuticals

Principles and Case Studies


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.

Download epub2

Read also

Shriek While You Can!

This poetry collection is divided into six sections by subject, placed in the following order: Humor, Family, Reflections, Nature, Adventures, and Livi. Livi is my young granddaughter. These poems all relate my feelings about actual events. I have attempted to write clearly enough for the readers to feel what I felt as I wrote these poems. In…

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.

Show more...

How to download book

Buy this book

You can buy this book now only for $103.69. This is the lowest price for this book.

Buy book

Download book free

If you want to download this book for free, please register, approve your account and get one book for free.


After that you may download book «Quality by Design for Biopharmaceuticals»:

Download XML Book: