The interface of medical devices and pharmaceuticals: Part II.
The technical challenges of developing combination products were addressed in Part I of this two part article. Part II reviews the preclinical tests and shelf-life testing that are required using drug eluting stents and drug eluting beads as examples. Regulatory considerations and ways to simplify development are also examined.
Biocompatibles UK Ltd, Farnham, UK. sean.willis@biocompatibles.com
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D000818:Animals; D024221:Antineoplastic Protocols; D004317:Doxorubicin / Q000008:administration & dosage; D016503:Drug Delivery Systems / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D054855:Drug-Eluting Stents / Q000191:economics / Q000592:standards*; D004621:Embolization, Therapeutic / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design / Q000191:economics / Q000592:standards; D019544:Equipment Failure Analysis / Q000379:methods; D004869:Equipment Safety / Q000379:methods; D033161:Government Regulation; D006801:Humans; D008863:Microspheres; D009369:Neoplasms / Q000628:therapy; D015363:Quinolones; D054928:Validation Studies as Topic; D014656:Vascular Surgical Procedures
D015363:Quinolones; C494925:orixalone A; D004317:Doxorubicin