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Kleinster Preis: 92,99 €, größter Preis: 223,72 €, Mittelwert: 140,81 €
Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley Series in Biotechnology and Bioengineering) - Anurag S. Rathore, Rohin Mhatre
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Anurag S. Rathore, Rohin Mhatre:

Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley Series in Biotechnology and Bioengineering) - gebunden oder broschiert

2009, ISBN: 0470282339

[SR: 1933189], Hardcover, [EAN: 9780470282335], John Wiley & Sons, John Wiley & Sons, Book, [PU: John Wiley & Sons], 2009-06-04, John Wiley & Sons, This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students., 270769, Biomedical Engineering, 270768, Ancillary Services, 270767, Medical & Healthcare Practitioners, 74, Health, Family & Lifestyle, 1025612, Subjects, 266239, Books, 270785, Pharmacy - Dispensing, 270768, Ancillary Services, 270767, Medical & Healthcare Practitioners, 74, Health, Family & Lifestyle, 1025612, Subjects, 266239, Books, 270945, Pharmacology, 270906, Other Branches of Medicine, 270767, Medical & Healthcare Practitioners, 74, Health, Family & Lifestyle, 1025612, Subjects, 266239, Books, 278004, Chemistry, 278005, Analytical Chemistry, 277913, Biochemistry, 922214, Education, 922228, Geochemistry, 278012, Inorganic Chemistry, 278015, Laboratory Techniques & Experiments, 278016, Mineralogy, 278017, Organic Chemistry, 278020, Physical Chemistry, 922212, Reference, 57, Science & Nature, 1025612, Subjects, 266239, Books, 278116, Bioengineering, 278115, Engineering & Technology, 57, Science & Nature, 1025612, Subjects, 266239, Books, 564342, Chemistry, 564334, Scientific, Technical & Medical, 1025612, Subjects, 266239, Books

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Quality by Design for Biopharmaceuticals - Rathore, Anurag S.; Mhatre, Rohin
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ISBN: 9780470282335

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Anurag S. Rathore received his PhD in chemical engineering from 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. Science Science eBook, Wiley

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This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students., [PU: Wiley]

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Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley Series in Biotechnology and Bioengineering) - gebunden oder broschiert

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Quality by Design for Biopharmaceuticals: Principles and Case Studies
Autor:

Anurag S. Rathore, Rohin Mhatre

Titel:

Quality by Design for Biopharmaceuticals: Principles and Case Studies

ISBN-Nummer:

0470282339

This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Detailangaben zum Buch - Quality by Design for Biopharmaceuticals: Principles and Case Studies


EAN (ISBN-13): 9780470282335
ISBN (ISBN-10): 0470282339
Gebundene Ausgabe
Erscheinungsjahr: 2009
Herausgeber: John Wiley & Sons
288 Seiten
Gewicht: 0,590 kg
Sprache: eng/Englisch

Buch in der Datenbank seit 26.03.2010 20:38:58
Buch zuletzt gefunden am 13.02.2017 18:49:28
ISBN/EAN: 0470282339

ISBN - alternative Schreibweisen:
0-470-28233-9, 978-0-470-28233-5

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