The Combination Products Handbook

1949,-

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<P>Combination products are therapeutic and diagnostic products that combine drugs, devices, and/<BR>or biological products. According to the US Food and Drug Administration (FDA), ¿a combination<BR>product is one composed of any combination of a drug and a device; a biological product and<BR>a device; a drug and a biological product; or a drug, device and a biological product.¿ Examples<BR>include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-eluting<BR>stents, and kits containing drug administration devices co-packaged with drugs and/or biological<BR>products. This handbook provides the most up-to-date information on the development of combination<BR>products, from the technology involved to successful delivery to market. The authors present<BR>important and up-to-the-minute pre- and post-market reviews of combination product regulations,<BR>guidance, considerations and best practices.</P><P>This handbook:</P><P>¿  Brings clarity of unders