Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition - Brossura

 
9781032918143: Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition
Brossura
ISBN 10: 1032918144 ISBN 13: 9781032918143
Casa editrice: CRC Press, 2024

Sinossi

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).

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Informazioni sull?autore

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

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
CRC Press
Data di pubblicazione
2024
Lingua
Inglese
ISBN 10 
1032918144
ISBN 13 
9781032918143
Rilegatura
Copertina flessibile
Numero edizione
2
Numero di pagine
624
Redattore
Alsante Karen M., Reed Robert A., Baertschi Steven W.
Contatto del produttore
non disponibile
Persona responsabile
non disponibile

Altre edizioni note dello stesso titolo

9781439801796: Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition

Edizione in evidenza

ISBN 10:  1439801797 ISBN 13:  9781439801796
Casa editrice: CRC Press, 2011
Rilegato