Trials and Tribulations

Peter Adams, Alan Daviesand 2 more

September 1, 2004

1 Min Read
Trials and Tribulations

Originally Published MX September/October 2004


Conducting clinical trials for combination products will lead manufacturers into a whole new world.

Peter Adams, Alan Davies, Eduardo March, William K. Sietsema

Development of therapeutic products containing a drug and medical device in combination has blurred the traditional demarcation that exists between the two. While drug-device combinations have existed for some time (e.g., catheters coated with heparin and bone cements containing antibiotics), new device systems capable of delivering drugs in a controlled manner are entering the market (e.g., drug-eluting stents for the treatment of cardiovascular disease). It is anticipated that the number of such products, utilizing well-known medicinals in combination with novel drug-delivery systems, will grow significantly in the coming years. This growth will in turn be accompanied by increasing difficulties in determining the path for approval by regulatory agencies.

Drugs versus Devices

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