USFDA-Guideline Based Validation of Testing Method for Ciprofloxacin in Indonesian Serum Specimen
Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugsshould shown 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...
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| Main Authors: | , , |
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| Format: | Conference or Workshop Item NonPeerReviewed |
| Language: | English |
| Published: |
2009
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| Subjects: | |
| Online Access: | https://repository.ugm.ac.id/275152/1/ICS%20Tri%20joko.pdf https://repository.ugm.ac.id/275152/ |
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| Institution: | Universitas Gadjah Mada |
| Language: | English |