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.
Willis
S L
SL
Biocompatibles UK Ltd, Farnham, UK. sean.willis@biocompatibles.com
Lewis
A L
AL
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