Téléchargez le livre : Sterile Product Development

Sterile Product Development

Formulation, Process, Quality and Regulatory Considerations

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Éditeur :

Springer


Collection :

AAPS Advances in the Pharmaceutical Sciences Series

Paru le : 2013-10-12



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Description

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.
Pages
585 pages
Collection
AAPS Advances in the Pharmaceutical Sciences Series
Parution
2013-10-12
Marque
Springer
EAN papier
9781461479772
EAN EPUB
9781461479789
Informations sur l'ebook
Nombre pages copiables
5
Nombre pages imprimables
58
Taille du fichier
3789 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
304,89 €

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