Pediatric Drug Development: Concepts and Applications - Couverture rigide

Mulberg, Andrew E.; Murphy, Dianne; Dunne, Julia; Mathis, Lisa L.

Couverture rigide

ISBN 10 : 1118312155 ISBN 13 : 9781118312155

Editeur : Wiley-Blackwell, 2013

Synopsis

Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.

A propos du livre

À propos de l?auteur

Andrew E. Mulberg, Division Deputy Director, Gastroenterology and Inborn Error Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, US

Dianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, US

Julia Dunne, Vigilance and Risk Management in Medicines (VRMM), Medicines and Healthcare Products Regulatory Agency, London, UK

Lisa L. Mathis, Executive Director for Global Regulatory Affairs and Safety (GRAAS), Amgen Incorporated, Thousand Oaks, California, US

Détails de l'édition

• Éditeur: Wiley-Blackwell
• Date d'édition: 2013
• Langue: anglais
• ISBN 10: 1118312155
• ISBN 13: 9781118312155
• Reliure: Relié
• Numéro d'édition: 2
• Nombre de pages: 624
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible