Please note: In order to keep Hive up to date and provide users with the best features, we are no longer able to fully support Internet Explorer. The site is still available to you, however some sections of the site may appear broken. We would encourage you to move to a more modern browser like Firefox, Edge or Chrome in order to experience the site fully.

Supporting your high street Find out how »
The Combination Products Handbook : A Practical Guide for Combination Products and Other Combined Use Systems, Hardback Book

The Combination Products Handbook : A Practical Guide for Combination Products and Other Combined Use Systems Hardback

Edited by Susan (Combination products Consulting Services LLC, USA) Neadle

Hardback

Only a few left - usually despatched within 24 hours

Description

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products.

This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market.

The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook:Brings clarity of understanding for global combination products guidance and regulationsReviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-marketReviews medical product classification and assignment issues faced by global regulatory authorities and industryThe editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors.

Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

Information

£145.00

Only a few left - usually despatched within 24 hours
Add to Basket
Sign in to add to wishlist
 
Free Home Delivery

on all orders

 
Pick up orders

from local bookshops

Information