USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN
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 administrated...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Department of Chemistry, Universitas Gadjah Mada
2010-06-01
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| Series: | Indonesian Journal of Chemistry |
| Online Access: | https://jurnal.ugm.ac.id/ijc/article/view/21494 |