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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Bibliographic Details
Main Authors: Raharjo, Tri Joko, Hakim, Arief Rahman, Sismindari, Sismindari
Format: Conference or Workshop Item
Language:English
Published: 2009
Subjects:
Online Access:https://repository.ugm.ac.id/275152/1/ICS%20Tri%20joko.pdf