Benefit-Risk Assessment of Medicines
-15%
portes grátis
Benefit-Risk Assessment of Medicines
The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Leong, James; Salek, Sam; Walker, Stuart
Springer International Publishing AG
10/2016
317
Mole
Inglês
9783319367675
15 a 20 dias
5037
Descrição não disponível.
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Benefit-risk assessment;Decision-making;Effective communication;Regulatory authorities;Universal framework
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
