ISBN 9780853695677,Development and Control of Medicines and Medical Devices

Development and Control of Medicines and Medical Devices

Rs2520 Rs2607 3% OFF

Availability: Available

Usually ships in: 2-3 business days

(Free Delivery)

We Accept
ISBN 9780853695677
Check delivery information
 
ISBN 9780853695677
Publisher

Pharmaceutical Press

Publication Year 2005
ISBN-13

ISBN 9780853695677

ISBN-10 0853695679
Binding

Hardback

Number of Pages 256 Pages
Language (English)
Subject

Medical genetics

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
Scroll