Quality by Design for Biopharmaceuticals / Wiley Series on Biotechnology (ePub)
Principles and Case Studies
(Sprache: Englisch)
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...
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...
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Produktinformationen zu „Quality by Design for Biopharmaceuticals / Wiley Series on Biotechnology (ePub)“
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.
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.
Autoren-Porträt
Anurag S. Rathore received his PhD in chemical engineeringfrom Yale University and is the Director of Process Development,
Amgen Inc. His areas of interest include process development,
scale-up, technology transfer, process validation, process
analytical technology, and quality by design. He has authored more
than 100 publications and presentations in these areas and serves
on the editorial advisory boards for Biotechnology Progress,
BioPharm International, Pharmaceutical Technology Europe, Journal
of Biochemical and Biophysical Methods, and Separation and
Purification Reviews.
Rohin Mhatre is a Senior Director in the BioProcess
Development department at Biogen Idec, Cambridge, Massachusetts,
and has been with the company since 1996. His group is responsible
for development of analytical methods and product characterization
to support the process and formulation development of early and
late stage clinical programs. Mhatre is also leading the QbD
initiative within Biogen Idec. He has authored several publications
and been an invited speaker to numerous scientific meetings.
Bibliographische Angaben
- 2011, 1. Auflage, 312 Seiten, Englisch
- Herausgegeben: Anurag S. Rathore, Rohin Mhatre
- Verlag: John Wiley & Sons
- ISBN-10: 1118210913
- ISBN-13: 9781118210918
- Erscheinungsdatum: 20.09.2011
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- Größe: 15 MB
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Sprache:
Englisch
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