Pharmaceutical Stress Testing: Predicing Drug Degradation - Couverture rigide

Livre 47 sur 80: Drugs and the Pharmaceutical Sciences
 
9781439801796: Pharmaceutical Stress Testing: Predicing Drug Degradation
Couverture rigide
ISBN 10 : 1439801797 ISBN 13 : 9781439801796
Editeur : CRC Press Inc, 2011

Synopsis

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years.

Key features include:

  • A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience.
  • 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations
  • Updated methodologies for predicting drug stability and degradation pathways
  • Best practice models to follow
  • An expanded Frequently Asked Questions section

This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

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

À propos de l?auteur

Steven W. Baertschi, Karen M. Alsante, Robert A. Reed

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

Éditeur
CRC Press Inc
Date d'édition
2011
Langue
anglais
ISBN 10 
1439801797
ISBN 13 
9781439801796
Reliure
Relié
Numéro d'édition
2
Nombre de pages
612
Éditeur
Baertschi Steven W., Alsante Karen M., Reed Robert A.
Coordonnées du fabricant
non disponible
Personne responsable
gpsr@libri.de
gpsr@libri.de

Friedensallee 273
Hamburg
22763
Allemagne

Autres éditions populaires du même titre

9780849359194: Pharmaceutical Stress Testing : Predicting Drug Degradation

Edition présentée

ISBN 10 :  0849359198 ISBN 13 :  9780849359194
Editeur : CRC Press, 2005
Couverture rigide