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The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems 1st Edition by Susan Neadle ISBN 9781032291628 1032291621

Name: The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems 1st Edition by Susan Neadle ISBN 9781032291628 1032291621
SKU: EB-49472076
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The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems 1st Edition Susan Neadle (Editor) Digital Instant Download

Author(s): Susan Neadle (editor)

ISBN(s): 9781032291628, 1032291621

Edition: 1

File Details: PDF, 47.96 MB

Year: 2023

Language: English

SKU: EB-49472076 Category: Computers - Computer Science Tag: Susan Neadle (editor)

Description

The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems 1st Edition by Susan Neadle – Ebook PDF Instant Download/Delivery: 9781032291628 ,1032291621
Full download The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems 1st Edition after payment

Product details:

ISBN 10: 1032291621
ISBN 13: 9781032291628
Author: Susan Neadle

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 regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The 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.

The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems 1st Edition Table of contents:

PART 1 Foundation

Chapter 1 Introduction: Key Considerations Advanced by this Handbook

Chapter 2 What Is a Combination Product?

Chapter 3 Combination Products Regulatory Strategies

Chapter 4 Combination Products Current Good Manufacturing Practices (cGMPs)

Chapter 5 Combination Products Integrated Development

Chapter 6 Combination Products Risk Management

Chapter 7 Human Factors Engineering in the Design, Development, and Lifecycle of Combination Products

Chapter 8 Combination Products Post-market Lifecycle Management

9A Combination Products Inspection Readiness: Best Practices and Considerations

9B US Combination Product Inspections

PART 2 Special Topics

Chapter 10 Considerations for Supplier Quality: Raw Materials, Components, and Constituent parts

Chapter 11 Analytical Testing Considerations for Combination Products

Chapter 12 Considerations for Development of Biological Products

Chapter 13 Digital Combination Products and Software

Chapter 14 General Overview of Global Combination Product Regulatory Landscape

Appendix: Global Combination Product Regulatory Framework Comparative Overview

Glossary

Index

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Tags: Susan Neadle, Combination Products, Combined Use Systems