Combination products: regulatory challenges and successful product development
Auteur :
Gopalaswamy, Smita / Gopalaswamy, Venky
Éditeur :
Taylor & Francis Inc
ISBN :
9781420064469
Date de publication :
22 avr. 2008
Dimensions :
23,4 x 15,6 cm
Poids :
544 g
Langue :
Anglais
Pays d'origine :
USA
Focusing on the developmental process for combination products - those that combine a drug with a device such as a drug-eluting stent, this book augments the guidance provided by the FDA. It shows how to: establish a design and development plan, giving consideration to regulatory expectations, resource requirements, and manufacturing challenges.