Development and Control of Medicines and Medical Devices - Tapa dura

Harman, Dr Robin J.

 
9780853695677: Development and Control of Medicines and Medical Devices
Tapa dura
ISBN 10: 0853695679 ISBN 13: 9780853695677
Editorial: Pharmaceutical Press, 2005

Sinopsis

This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European regulatory authorities for medicine and medicinal devices (the MHRA and the EMEA), and of the National Institute for Clinical Excellence (NICE), are explained. A review of the ICH process, and of the activities of the US FDA and the World Health Organization (WHO) in drug and device regulation illustrate how other countries control these products. Providing a comprehensive single-volume review, Development and Control of Medicines and Medicinal Devices is an invaluable reference for all students undertaking healthcare studies and for all pharmacists. It is also an essential source for all working in the pharmaceutical and medical devices industries

"Sinopsis" puede pertenecer a otra edición de este libro.

Reseña del editor

This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European regulatory authorities for medicine and medicinal devices (the MHRA and the EMEA), and of the National Institute for Clinical Excellence (NICE), are explained. A review of the ICH process, and of the activities of the US FDA and the World Health Organization (WHO) in drug and device regulation illustrate how other countries control these products. Providing a comprehensive single-volume review, Development and Control of Medicines and Medicinal Devices is an invaluable reference for all students undertaking healthcare studies and for all pharmacists. It is also an essential source for all working in the pharmaceutical and medical devices industries

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
Pharmaceutical Press
Año de publicación
2005
Idioma
Inglés
ISBN 10 
0853695679
ISBN 13 
9780853695677
Encuadernación
Tapa dura
Número de páginas
256
Contacto del fabricante
no disponible
Persona responsable
no disponible