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

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

Author: Susan Neadle

Therapeutic and diagnostic products that mix medications , equipment and/or biological materials are known as combination products . A combination product is one that is made up 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 , according to the US Food and Drug Administration (FDA) .

Transdermal delivery systems , drug-eluting stents , prefilled syringes , pen injectors , autoinjectors , inhalers , prefilled syringes ,  autoinjectors , autoinjectors , autoinjectors and kits with drug administration devices combined with pharmaceutical and/or biological goods are a few examples . This manual offers the most recent information on the creation of combination goods, from the underlying technology to successful market entry . Pre- and post-market assessments of foreign combination product legislation , recommendations , considerations and best practices are provided by the authors .

They are significant and up-to-date . This manual :

• Enhances comprehension of guidelines and rules for worldwide combination products

• Examines the most recent best practices and cutting-edge considerations for the whole lifetime of a combination product , from pre-market to post-market .

• Examines the classification and assignment challenges that the industry and international regulatory bodies face .

With over 35 years of experience in the field , the editor is a well-known international authority on combination products and medical devices . He also has a fantastic team of contributors . Association for the Advancement of Medical Instrumentation (AAMI) endorsement .

See Also : The Private Life of the Genome (Original PDF from Publisher)

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