Development and Control of Medicines and Medical Devices

Dr Robin J. Harman,

ISBN 10: 0853695679 / ISBN 13: 9780853695677

Edité par Pharmaceutical Press, 2004

A propos de cet article

New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service.

N° de réf. du vendeur ABEJUNE24-137651

Détails bibliographiques

• Titre: Development and Control of Medicines and Medical Devices
• Éditeur: Pharmaceutical Press
• Date de parution: 2004
• Langue: anglais
• ISBN à 10 chiffres: 0853695679
• ISBN à 13 chiffres: 9780853695677
• Reliure: Couverture rigide
• État de l'article: Brand New

A propos de ce titre

Synopsis

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