Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics
نویسندگان
چکیده
منابع مشابه
Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics
BACKGROUND Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. Physicochemical methods are preferred instead of biological ass...
متن کاملMethods of Rapid Microbiological Assay and Their Application to Pharmaceutical and Medical Device Fabrication.
There are several rapid microbiological methods becoming available that have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some me...
متن کاملconstruction and validation of translation metacognitive strategy questionnaire and its application to translation quality
like any other learning activity, translation is a problem solving activity which involves executing parallel cognitive processes. the ability to think about these higher processes, plan, organize, monitor and evaluate the most influential executive cognitive processes is what flavell (1975) called “metacognition” which encompasses raising awareness of mental processes as well as using effectiv...
Therapeutic equivalence requires pharmaceutical, pharmacokinetic, and pharmacodynamic identities: true bioequivalence of a generic product of intravenous metronidazole.
Animal models of infection have been used to demonstrate the therapeutic failure of "bioequivalent" generic products, but their applicability for this purpose requires the accurate identification of those products that are truly bioequivalent. Here, we present data comparing one intravenous generic product of metronidazole with the innovator product in a neutropenic mouse thigh anaerobic infect...
متن کاملapplication of brand personality scale in automobile industry: the study of samand’s brand personality dimensions
این تحقیق شخصیت برند سمند را در ایران با استفاده از مدل پنج بعدی آکر (1997) بعنوان یک چهارچوب بطور توصیفی سنجیده است. بنابر این چهارچوب که دراصل در 42 جزء (42 ویزگی شخصیتی) ودر پنج بعد شخصیتی طراحی شده بود ودر کشورها وصنایع مختلف آزموده شده بود, پرسنامه به زبان فارسی ترجمه شده و با استفاده از روشهای ترجمه معکوس و مصاحبه عمیق با 12 متخصص ایرانی به 38 جزء کاهش یافت. و نظرسنجی ای در پنج نمایندگی ا...
15 صفحه اولذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: BMC Clinical Pharmacology
سال: 2009
ISSN: 1472-6904
DOI: 10.1186/1472-6904-9-1