Proceedings from the Workshop on Science-Based Assessment Accelerating Product Development of Combination Medical Devices (2004) / Chapter Skim
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4 Drug-Eluting Stents
4 Drug-Eluting Stents
Pages 18-20
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From page 18... ...
Polymer carriers are one of the leading anti-restenosis technologies. Their advantages include mechanical integrity/handling; precision dose control with uniform drug distribution, uniform release, the ability to modify release, and the ability to prevent overdosing; and versatility of use with other drugs and platforms.
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From page 19... ...
Physical testing includes testing for specification conformance and for clinically desirable stent characteristics, such as radial strength, uniformity, dimensional verification, and kink and crush resistance. Preclinical safety information required for drug-eluting stents includes toxicological studies.
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From page 20... ...
Increases of four times in the total loaded dose of the moderate release formulation demonstrate similar biological responses across doses. In an overlap system, the response to the moderate release formulation remains well within biologically compatible dosing.
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