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- bioekvivalenssitutkimuksen aikana koevalmisteen biosaatavuuden osoitettiin olevan pienempi
- the test product demonstrated lower bioavailability compared to eqvalan, the cited reference
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
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.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
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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.
Last Update: 2008-03-04
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
