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...

Full description

Saved in:
Bibliographic Details
Main Author: Perpustakaan UGM, i-lib
Format: Article NonPeerReviewed
Published: [Yogyakarta] : Universitas Gadjah Mada 2010
Subjects:
Online Access:https://repository.ugm.ac.id/28070/
http://i-lib.ugm.ac.id/jurnal/download.php?dataId=11133
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Universitas Gadjah Mada
Be the first to leave a comment!
You must be logged in first