Articles liés à Parenteral Quality Control: Sterility, Pyrogen, Particulate,...

Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing - Couverture rigide

Akers, Michael J.; Larrimore, Daniel S.; Guazzo, Dana Morton

 
9780824708856: Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing
Couverture rigide
ISBN 10 : 0824708857 ISBN 13 : 9780824708856
Editeur : Marcel Dekker Inc, 2002

Synopsis

Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
Marcel Dekker Inc
Date d'édition
2002
Langue
anglais
ISBN 10 
0824708857
ISBN 13 
9780824708856
Reliure
Relié
Numéro d'édition
3
Nombre de pages
408
Coordonnées du fabricant
non disponible
Personne responsable
non disponible