Denna webbshop är stängd för köp.
Klicka här för mer information

Benefit-Risk Assessment of Medicines
  • Undertitel The Development and Application of a Universal Framework for Decision-Making and Effective Communication
  • Författare:

    James Leong

  • Förlag:

    Adis

  • Bandtyp: Inbunden
  • Språk: Engelska
  • Utgiven: 201504
  • Antal sidor: 317
  • Upplaga: 2015 ed., 
    Vikt i gram: 799
  • ISBN10:331915804X
  • ISBN13:9783319158044

Benefit-Risk Assessment of Medicines

(Inbunden)
Beskrivning:

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.

Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area.

The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

Kundrecensioner och bloggar

Sök fler böcker:

Kunder som köpt denna bok har
även köpt:
Skotten i Köpenhamn :  ett reportage om
Vintermörker :  samlade spänningshistori
Uppgång och fall
Uppgång och fall
av Strömquist, Liv
Miniatyrmakaren
Miniatyrmakaren
av Burton, Jessie
Min mors självbiografi
Min mors självbiografi
av Kincaid, Jamaica