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Titlebook: Sterile Product Development; Formulation, Process Parag Kolhe,Mrinal Shah,Nitin Rathore Book 2013 American Association of Pharmaceutical Sc

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發(fā)表于 2025-3-21 18:07:33 | 只看該作者 |倒序瀏覽 |閱讀模式
書目名稱Sterile Product Development
副標題Formulation, Process
編輯Parag Kolhe,Mrinal Shah,Nitin Rathore
視頻videohttp://file.papertrans.cn/878/877421/877421.mp4
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-
叢書名稱AAPS Advances in the Pharmaceutical Sciences Series
圖書封面Titlebook: Sterile Product Development; Formulation, Process Parag Kolhe,Mrinal Shah,Nitin Rathore Book 2013 American Association of Pharmaceutical Sc
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
關(guān)鍵詞Development; Formulation; Lyophilized parenterals; PEGylated biotherapeutics; Parenteral drug delivery; P
版次1
doihttps://doi.org/10.1007/978-1-4614-7978-9
isbn_softcover978-1-4939-5205-2
isbn_ebook978-1-4614-7978-9Series ISSN 2210-7371 Series E-ISSN 2210-738X
issn_series 2210-7371
copyrightAmerican Association of Pharmaceutical Scientists 2013
The information of publication is updating

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Herb Lutz,Randy Wilkins,Christina Carbrelloatabases, acceleration, propagation, and prediction of individual SEP event, statistical models of solar cosmic rays (SCR). 7. Existing empirical techniques of 978-90-481-6389-2978-94-017-0301-7Series ISSN 0067-0057 Series E-ISSN 2214-7985
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d in the reader’s own programs. This book will be an invaluable aid to medical physicists when performing calculations relating to patient dose and image quality, and will also prove useful for diagnostic radiologists and engineers.978-3-662-51754-3978-3-642-11241-6
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d in the reader’s own programs. This book will be an invaluable aid to medical physicists when performing calculations relating to patient dose and image quality, and will also prove useful for diagnostic radiologists and engineers.978-3-662-51754-3978-3-642-11241-6
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Martin A. Joyce Ph.D.,Leonore C. Witchey-Lakshmanan Ph.D.d in the reader’s own programs. This book will be an invaluable aid to medical physicists when performing calculations relating to patient dose and image quality, and will also prove useful for diagnostic radiologists and engineers.978-3-662-51754-3978-3-642-11241-6
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Roger H. Pak,Rory F. Finnd in the reader’s own programs. This book will be an invaluable aid to medical physicists when performing calculations relating to patient dose and image quality, and will also prove useful for diagnostic radiologists and engineers.978-3-662-51754-3978-3-642-11241-6
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Jason D. Ehrick,Samir A. Shah,Charles Shaw,Vitthal S. Kulkarni,Intira Coowanitwong,Samiran De,Julie d in the reader’s own programs. This book will be an invaluable aid to medical physicists when performing calculations relating to patient dose and image quality, and will also prove useful for diagnostic radiologists and engineers.978-3-662-51754-3978-3-642-11241-6
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