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商品詳細
Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations. Softcover reprint of the original 1st ed. 2013
・ISBN 978-1-4939-5205-2 paper EUR 279.99
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| 著者・編者 | Kolhe, Parag / Shah, Mrinal / Rathore, Nitin (eds.), |
|---|---|
| シリーズ | (AAPS Advances in the Pharmaceutical Sciences Series) |
| 出版社 | (Springer-Verlag New York Inc., US) |
| 出版年月 | 2016 |
| ページ数 | 585 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A04-83673＞ |
解説
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:
* Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines
* Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures
* Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers
This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.