USFDA-GUIDELINEBASED VALIDATION OF TESTING METHODFOR RIFAMPICIN IN INDONESIANSERUM SPECIMEN
ABSTRACT Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugs should show bioequivalence with the originator drug prior to registration. Bioequivalence testing (BE-testing)has to be performed to the people that represented of population to which the drug to be admin...
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Format: | Article NonPeerReviewed |
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[Yogyakarta] : Universitas Gadjah Mada
2010
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Online Access: | https://repository.ugm.ac.id/28070/ http://i-lib.ugm.ac.id/jurnal/download.php?dataId=11133 |
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Institution: | Universitas Gadjah Mada |