Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences) - Softcover

 
9781032918143: Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences)
Softcover
ISBN 10: 1032918144 ISBN 13: 9781032918143
Verlag: CRC Press, 2024

Inhaltsangabe

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).

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Über die Autorin bzw. den Autor

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

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Verlag
CRC Press
Erscheinungsdatum
2024
Sprache
Englisch
ISBN 10 
1032918144
ISBN 13 
9781032918143
Einband
Tapa blanda
Auflage
2
Anzahl der Seiten
624
Herausgeber
Alsante Karen M., Reed Robert A., Baertschi Steven W.
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
Nicht verfügbar

Weitere beliebte Ausgaben desselben Titels

9781439801796: Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition: 153 (Drugs and the Pharmaceutical Sciences)

Vorgestellte Ausgabe

ISBN 10:  1439801797 ISBN 13:  9781439801796
Verlag: CRC Press, 2011
Hardcover