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Drug Eluting Coronary Stent System [Regulatives / Guidelines]

posted by bhaveshmk4u – 2009-08-20 14:22 (6157 d 17:57 ago) – Posting: # 4077
Views: 3,183

Hello !

I would like to know about BA/BE Study for Drug Eluting Coronary Stent System. Is it possible to conduct Bioequivalence study for medical device like Drug Eluting Stent ?

Please guide me if any guideline available for BA/BE Study, specially for Drug Eluting Coronary Stent.

Thanks !

Complete thread:

Drug Eluting Coronary Stent Systembhaveshmk4u 2009-08-20 12:22
- DES (NDA guidance) Helmut 2009-08-20 14:54
  - DES (NDA guidance) bhaveshmk4u 2009-08-25 12:08

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