| 书目名称 | Sterile Product Development | | 副标题 | Formulation, Process | | 编辑 | Parag Kolhe,Mrinal Shah,Nitin Rathore | | 视频video | | | 概述 | Addresses the key concepts and applications in sterile product area.Illustrates fundamental understanding as well as practical implications in sterile product development life cycle.Broad range of in- | | 丛书名称 | AAPS Advances in the Pharmaceutical Sciences Series | | 图书封面 |  | | 描述 | .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 | | 出版日期 | Book 2013 | | 关键词 | Development; Formulation; Lyophilized parenterals; PEGylated biotherapeutics; Parenteral drug delivery; P | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4614-7978-9 | | isbn_softcover | 978-1-4939-5205-2 | | isbn_ebook | 978-1-4614-7978-9Series ISSN 2210-7371 Series E-ISSN 2210-738X | | issn_series | 2210-7371 | | copyright | American Association of Pharmaceutical Scientists 2013 |
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发表于 2025-3-21 18:07:33
