전문 번역가, 번역 회사, 웹 페이지 및 자유롭게 사용할 수 있는 번역 저장소 등을 활용합니다.
- bioekvivalenssitutkimuksen aikana koevalmisteen biosaatavuuden osoitettiin olevan pienempi
- the test product demonstrated lower bioavailability compared to eqvalan, the cited reference
마지막 업데이트: 2012-04-10
사용 빈도: 3
품질:
farmakokineettisten tietojen perusteella on mahdollista, että koevalmisteen biosaatavuus on systeemisesti pienempi kuin vertailulääkevalmisteen biosaatavuus.
during the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance emea/ cvmp/ 016/ 00-corr- final), however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
마지막 업데이트: 2011-10-23
사용 빈도: 1
품질:
경고: 이 정렬은 잘못되었을 수 있습니다.
잘못된 경우 삭제해 주십시오.
lausuntopyyntömenettelyn aikana on osoitettu, että toimitetussa bioekvivalenssitutkimuksessa bioekvivalenssia (sellaisena kuin se on määritetty voimassa olevassa ohjeistuksessa emea/cvmp/016/00-corr-final) ei ole osoitettu riittävän selvästi.farmakokineettisten tietojen perusteella on mahdollista, että koevalmisteen biosaatavuus on systeemisesti pienempi kuin vertailulääkevalmisteen biosaatavuus.
during the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance emea/cvmp/016/00-corr-final) , however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
마지막 업데이트: 2008-03-04
사용 빈도: 1
품질:
경고: 이 정렬은 잘못되었을 수 있습니다.
잘못된 경우 삭제해 주십시오.
