Quality by design for biopharmaceuticals: principles and case studies
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| Format: | Electronic eBook |
|---|---|
| Language: | English |
| Published: |
Hoboken, N.J.
Wiley
©2009
|
| Series: | Wiley series in biotechnology and bioengineering
|
| Subjects: | |
| Online Access: | FRO01 UBG01 Volltext |
| Item Description: | Includes bibliographical references and index Wiley Series in Biotechnology and bioengineering. Anurag S. Rathore, Series Editor. Quality by Design for Biopharmaceuticals. Principles and Case Studies. Edited by. Anurag S. Rathore. Rohin Mhatre. 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 |
| Physical Description: | 1 Online-Ressource (xvi, 288 pages, [16] pages of plates) |
| ISBN: | 9780470466315 0470466316 9780470466308 0470466308 1282368435 9781282368439 |
Staff View
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| spelling | Quality by design for biopharmaceuticals principles and case studies edited by Anurag S. Rathore and Rohin Mhatre Hoboken, N.J. Wiley ©2009 1 Online-Ressource (xvi, 288 pages, [16] pages of plates) txt rdacontent c rdamedia cr rdacarrier Wiley series in biotechnology and bioengineering Includes bibliographical references and index Wiley Series in Biotechnology and bioengineering. Anurag S. Rathore, Series Editor. Quality by Design for Biopharmaceuticals. Principles and Case Studies. Edited by. Anurag S. Rathore. Rohin Mhatre. 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 Technology, Pharmaceutical Biological Products Biotechnology Pharmaceutical Preparations Quality Control MEDICAL / Drug Guides bisacsh MEDICAL / Nursing / Pharmacology bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh Pharmaceutical biotechnology / Quality control fast Medizin Pharmaceutical biotechnology / Quality control Qualitätskontrolle (DE-588)4047968-7 gnd rswk-swf Biologika (DE-588)7689632-8 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Biologika (DE-588)7689632-8 s Qualitätskontrolle (DE-588)4047968-7 s 2\p DE-604 Rathore, Anurag S. Sonstige oth Mhatre, Rohin Sonstige oth Erscheint auch als Druck-Ausgabe, Hardcover 0-470-28233-9 Erscheint auch als Druck-Ausgabe, Hardcover 978-0-470-28233-5 https://onlinelibrary.wiley.com/doi/book/10.1002/9780470466315 Verlag URL des Erstveröffentlichers Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Quality by design for biopharmaceuticals principles and case studies Technology, Pharmaceutical Biological Products Biotechnology Pharmaceutical Preparations Quality Control MEDICAL / Drug Guides bisacsh MEDICAL / Nursing / Pharmacology bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh Pharmaceutical biotechnology / Quality control fast Medizin Pharmaceutical biotechnology / Quality control Qualitätskontrolle (DE-588)4047968-7 gnd Biologika (DE-588)7689632-8 gnd |
| subject_GND | (DE-588)4047968-7 (DE-588)7689632-8 (DE-588)4143413-4 |
| title | Quality by design for biopharmaceuticals principles and case studies |
| title_auth | Quality by design for biopharmaceuticals principles and case studies |
| title_exact_search | Quality by design for biopharmaceuticals principles and case studies |
| title_full | Quality by design for biopharmaceuticals principles and case studies edited by Anurag S. Rathore and Rohin Mhatre |
| title_fullStr | Quality by design for biopharmaceuticals principles and case studies edited by Anurag S. Rathore and Rohin Mhatre |
| title_full_unstemmed | Quality by design for biopharmaceuticals principles and case studies edited by Anurag S. Rathore and Rohin Mhatre |
| title_short | Quality by design for biopharmaceuticals |
| title_sort | quality by design for biopharmaceuticals principles and case studies |
| title_sub | principles and case studies |
| topic | Technology, Pharmaceutical Biological Products Biotechnology Pharmaceutical Preparations Quality Control MEDICAL / Drug Guides bisacsh MEDICAL / Nursing / Pharmacology bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh Pharmaceutical biotechnology / Quality control fast Medizin Pharmaceutical biotechnology / Quality control Qualitätskontrolle (DE-588)4047968-7 gnd Biologika (DE-588)7689632-8 gnd |
| topic_facet | Technology, Pharmaceutical Biological Products Biotechnology Pharmaceutical Preparations Quality Control MEDICAL / Drug Guides MEDICAL / Nursing / Pharmacology MEDICAL / Pharmacology MEDICAL / Pharmacy Pharmaceutical biotechnology / Quality control Medizin Qualitätskontrolle Biologika Aufsatzsammlung |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9780470466315 |
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