학회 |
한국고분자학회 |
학술대회 |
2008년 가을 (10/09 ~ 10/10, 일산킨텍스) |
권호 |
33권 2호 |
발표분야 |
기능성 고분자 |
제목 |
Biomedical applicability of biocompatable or biodegradable materials |
초록 |
Functional polymers and small molecules which are specially prepared for enhancing therapeutic efficacies of drugs or medical devices are indispensable to production of medicines or medical devices or even regeneration of tissues. Even though their remarkably high efficacies of biomedical applications as reported in academic papers or patents, why are there small number of materials that are enrolled in Drug Master File (DMF) of FDA or Pharmacopeia? What are the factors or criteria that scientists or engineers who want to develop new biomaterials should consider previously in order to pass preclinical or clinical studies of them? In this talk, representative examples of biomaterials that are approved by regulatory department of government and hence used in commercial products are briefly reviewed and also preclinical test items of biomedical materials that are screened by Contract Research Organization (CRO) are introduced in order to recognize the end use of biomaterials. |
저자 |
성하수 |
소속 |
한국화학(연) |
키워드 |
Biomaterials; Dug Master File; Preclinical studies; Contract Research Organization
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E-Mail |
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