|
| Der Artikel wird am Ende des Bestellprozesses zum Download zur Verfügung gestellt. |
Benefit-Risk Assessment of Medicines
The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Sofort lieferbar | Lieferzeit: Sofort lieferbar I
ISBN-13:
9783319158051
Veröffentl:
2015
Seiten:
317
Autor:
James Leong
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
1 - PDF Watermark
Sprache:
Englisch
Beschreibung:
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox.
Prologue.- Preface.- Overview.- Approaches to utilising decision-making framework.- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities.- Development of a universal benefit-risk framework and template.- Implementation of the benefit-risk assessment template by mature agencies.- Implementation of the benefit- risk summary template by a maturing agency: A case study.- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada.- Conclusions and future directions.- References.
Kunden Rezensionen
Mehr zum Thema
Folgen Sie uns auf:
