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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Bibliographic Details
Main Author: Perpustakaan UGM, i-lib
Format: Article NonPeerReviewed
Published: [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

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