Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley Series in Biotechnology and Bioengineering Book 1)

by Anurag S. Rathore

5/5

$108.99

Hardcover

$108.99

eTextbook

$14.99

ISBN-13: 9780470282335

ISBN-10: 470282339


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.

Customer Reviews

GREAT BOOK -- GREAT SERVICE

5.0 rating
September 24, 2020

THANK YOU. Upon cursory examination, I am thrilled with the book. You people are great. Now I don’t have to type out everything — and it is very readable. I am so glad I cancelled my other order — book was very costly — and was going to take 3 weeks to get. Yet here you are, and you gave it to me quickly, conveniently — “right now!” WOW. I will certainly remember you. Thank you so much.

ADA

It Does Really Work

5.0 rating
September 24, 2020

I found this site and I was going to purchase the book when I saw the program to get it for free. I copy the link, email all my classmates on canvas, took a screen picture, and sent it to them, next morning I received the code and I applied to the cart and I got my pdf download. It’s real and the pdf is real and it works, all pages opened. Thank you so much!!!

Andriele

I was skeptical because there were only 5 star reviews

4.0 rating
September 23, 2020

But I got my textbook for $16 bucks. Put 4 stars so you could tell It was a real person making this lol.

Jamie Sansbury

Great Site

5.0 rating
May 12, 2020

Textbooks are a great and affordable price! Will definitely buy again.

T'Niya

LOVe the free textbook offer

5.0 rating
March 18, 2020

I sent a link to my classmates and was able to get my textbook for free. I wasn’t sure at first but thankful and happy I tried. I got to download the book immediately .

A MArtin

Attention

To ensure the safety of our staff and valued customers, we have made all of our textbooks fully downloadable and can be viewed on any device.