USFDA-Guideline Based Validation of Testing Method for Ciprofloxacin in Indonesian Serum Specimen

• المؤلفون الرئيسيون: Raharjo, Tri Joko, Hakim, Arief Rahman, Sismindari, Sismindari
• التنسيق: Conference or Workshop Item NonPeerReviewed
• اللغة: English
• منشور في: 2009
• الموضوعات: Separation Science; Pharmaceutical Sciences
• الوصول للمادة أونلاين: https://repository.ugm.ac.id/275152/1/ICS%20Tri%20joko.pdf; https://repository.ugm.ac.id/275152/

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...