Articoli correlati a Statistical Design and Analysis of Stability Studies
Sinossi
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.
After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.
To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
Informazioni sull?autore
Shein-Chung Chow
Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.
- EditoreRoutledge
- Data di pubblicazione2020
- ISBN 10 0367577682
- ISBN 13 9780367577681
- RilegaturaCopertina flessibile
- LinguaInglese
- Numero edizione1
- Numero di pagine348
- Contatto del produttorenon disponibile
Compra nuovo
Visualizza questo articolo
EUR 56,83
EUR 9,70 per la spedizione da Germania a Italia
Destinazione, tempi e costi
Risultati della ricerca per Statistical Design and Analysis of Stability Studies
Immagini fornite dal venditore
Statistical Design and Analysis of Stability Studies
Print on DemandDa: moluna, Greven, Germania
Valutazione del venditore 5 su 5 stelle
Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Shein-Chung ChowThe US Food and Drug Administration s Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies c. Codice articolo 594590479
Quantità: Più di 20 disponibili
Immagini fornite dal venditore
Statistical Design and Analysis of Stability Studies
Editore:
Chapman And Hall/CRC Jun 2020, 2020
ISBN 10: 0367577682
ISBN 13: 9780367577681
Nuovo
Taschenbuch
Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development. 350 pp. Englisch. Codice articolo 9780367577681
Quantità: 2 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Da: Majestic Books, Hounslow, Regno Unito
Valutazione del venditore 5 su 5 stelle
Condizione: New. pp. 348. Codice articolo 385862706
Quantità: 3 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Print on DemandDa: PBShop.store US, Wood Dale, IL, U.S.A.
Valutazione del venditore 5 su 5 stelle
PAP. Condizione: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Codice articolo IQ-9780367577681
Quantità: 15 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Da: GreatBookPrices, Columbia, MD, U.S.A.
Valutazione del venditore 5 su 5 stelle
Condizione: As New. Unread book in perfect condition. Codice articolo 41471171
Quantità: Più di 20 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Print on DemandDa: PBShop.store UK, Fairford, GLOS, Regno Unito
Valutazione del venditore 4 su 5 stelle
PAP. Condizione: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Codice articolo IQ-9780367577681
Quantità: 15 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Editore:
Taylor & Francis Ltd, 2020
ISBN 10: 0367577682
ISBN 13: 9780367577681
Nuovo
Paperback / softback
Da: THE SAINT BOOKSTORE, Southport, Regno Unito
Valutazione del venditore 5 su 5 stelle
Paperback / softback. Condizione: New. New copy - Usually dispatched within 4 working days. 644. Codice articolo B9780367577681
Quantità: 1 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Print on DemandDa: Revaluation Books, Exeter, Regno Unito
Valutazione del venditore 5 su 5 stelle
Paperback. Condizione: Brand New. 349 pages. 9.25x6.14x0.79 inches. In Stock. This item is printed on demand. Codice articolo __0367577682
Quantità: 1 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies
Da: GreatBookPricesUK, Woodford Green, Regno Unito
Valutazione del venditore 5 su 5 stelle
Condizione: As New. Unread book in perfect condition. Codice articolo 41471171
Quantità: Più di 20 disponibili
Foto dell'editore
Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)
Da: Ria Christie Collections, Uxbridge, Regno Unito
Valutazione del venditore 5 su 5 stelle
Condizione: New. In. Codice articolo ria9780367577681_new
Quantità: Più di 20 disponibili