Compartir
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (en Inglés)
Pisano, Douglas J. ; Mantus, David S. (Autor)
·
CRC Press
· Tapa Dura
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (en Inglés) - Pisano, Douglas J. ; Mantus, David S.
225,51 €
237,38 €
Ahorras: 11,87 €
Elige la lista en la que quieres agregar tu producto o crea una nueva lista
✓ Producto agregado correctamente a la lista de deseos.
Ir a Mis Listas
Origen: Reino Unido
(Costos de importación incluídos en el precio)
Se enviará desde nuestra bodega entre el
Martes 09 de Julio y el
Lunes 22 de Julio.
Lo recibirás en cualquier lugar de España entre 1 y 5 días hábiles luego del envío.
Reseña del libro "FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (en Inglés)"
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO's such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track
