Description

Book Synopsis

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 understand

    Table of Contents

    Chapter 1 Introduction

    Chapter 2 What is a Combination Product?

    Chapter 3 Regulatory Strategies

    Chapter 4 cGMPs

    Chapter 5 Integrated Development

    Chapter 6 Risk Management

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

    Chapter 8 Lifecycle Management: Design Transfer through Post Market

    Chapter 9

    • 9A. Best Practices and Considerations for Combination Products Inspection Readiness
    • 9B. US Combination Product Inspections

    Part 2: Special Topics

    Chapter 10 Supplier Quality Considerations

    Chapter 11 Analytical Testing Considerations

    Chapter 12 Biological Products Considerations

    Chapter 13 Connected Health

    Chapter 14 Evolving Global Regulatory Landscape

The Combination Products Handbook

    Product form

    A Hardback by Susan Neadle

    £999.99

    Includes FREE delivery

    Out of stock

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      Book details

      Publisher CRC Press
      Published 5/16/2023 12:00:00 AM
      ISBN-13 9781032291628
      978-1032291628
      ISBN-10 1032291621
      Also in:
      Biomedical engineering / Medical engineering Biology, life sciences

      Description

      Book Synopsis

      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 understand

        Table of Contents

        Chapter 1 Introduction

        Chapter 2 What is a Combination Product?

        Chapter 3 Regulatory Strategies

        Chapter 4 cGMPs

        Chapter 5 Integrated Development

        Chapter 6 Risk Management

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

        Chapter 8 Lifecycle Management: Design Transfer through Post Market

        Chapter 9

        • 9A. Best Practices and Considerations for Combination Products Inspection Readiness
        • 9B. US Combination Product Inspections

        Part 2: Special Topics

        Chapter 10 Supplier Quality Considerations

        Chapter 11 Analytical Testing Considerations

        Chapter 12 Biological Products Considerations

        Chapter 13 Connected Health

        Chapter 14 Evolving Global Regulatory Landscape

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