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논문 개요
| 기관명 | NDSL |
|---|---|
| 저널명 | 한국임상약학회지 = Korean journal of clinical pharmacy |
| ISSN | 1226-6051, |
| ISBN |
논문저자 및 소속기관 정보
| 저자(한글) | 최선옥,권광일,정성희,엄소영,정서정,김주일,정수연,김옥희,국립독성연구원 약리연구부 대사약물팀,충남대학교 약학대학,국립독성연구원 약리연구부 대사약물팀,국립독성연구원 약리연구부 대사약물팀,국립독성연구원 약리연구부 대사약물팀,국립독성연구원 약리연구부 대사약물팀,국립독성연구원 약리연구부 대사약물팀,국립독성연구원 약리연구부 대사약물팀 |
|---|---|
| 저자(영문) | |
| 소속기관 | |
| 소속기관(영문) | |
| 출판인 | |
| 간행물 번호 | |
| 발행연도 | 2005-01-01 |
| 초록 | A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies. |
| 원문URL | http://click.ndsl.kr/servlet/OpenAPIDetailView?keyValue=03553784&target=NART&cn=JAKO200503018259382 |
| 첨부파일 |
추가정보
| 과학기술표준분류 | |
|---|---|
| ICT 기술분류 | |
| DDC 분류 | |
| 주제어 (키워드) | food-effect,bioavailability,bioequivalence |