Articles liés à Follow-On Biologics: Background and Issues

Follow-On Biologics: Background and Issues - Couverture rigide

 
9781611220766: Follow-On Biologics: Background and Issues
Couverture rigide
ISBN 10 : 1611220769 ISBN 13 : 9781611220766
Editeur : Nova Science Publishers Inc, 2011

Synopsis

A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic, or biosimilar, is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesised via a chemical process. Biologics often require special handling (such as refrigeration) and are usually administered to patients via injection or infused directly into the bloodstream. This book provides a brief introduction to the relevant law, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a brief description of the biologics provisions in the new healthcare reform bill signed into law under President Obama, entitled the Patient Protection and Affordable Care Act (PPACA).

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
Nova Science Publishers Inc
Date d'édition
2011
Langue
anglais
ISBN 10 
1611220769
ISBN 13 
9781611220766
Reliure
Relié
Nombre de pages
148
Éditeur
Gutiérrez Daniel J
Coordonnées du fabricant
non disponible
Personne responsable
non disponible