Biodiversity, biodisparity, and bioequivalence
نویسندگان
چکیده
منابع مشابه
Bioequivalence and Bioequivalency Testing
PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency te...
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Two drug products are considered bioequivalent 'if their bio-availabilities ... are similar to such a degree that their effects, with respect to both efficacy and safety, will essentially be the same'. 1 The bioequivalence of two drug products is generally demonstrated through a clinical study in healthy volunteers, the so-called bioequivalence study. If bioequivalence is shown for two drug pro...
متن کاملBioequivalence & Bioavailability
Modeling and simulation methods are now commonly used in drug product development and regulatory drug review process. These applications include, but are not limited to: the development of biorelevant specifications, determination of bioequivalence matrixes for modified release products with rapid therapeutic onset, design of in vitro-in vivo correlations in a mechanistic framework, and predict...
متن کاملBioequivalence & Bioavailability
Atorvastatin is a lipid-lowering agent, approved for treatment once daily at 10-80 mg doses in adults and at 10-20 mg doses in children aged 10 years or older [15]. Following oral administration, atorvastatin is rapidly absorbed, and maximum plasma concentrations are achieved within 1 to 2 hours. Atorvastatin is extensively metabolized by cytochrome P450 3A4 to active metabolites: orthoand para...
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ژورنال
عنوان ژورنال: Ecology and Society
سال: 2010
ISSN: 1708-3087
DOI: 10.5751/es-03699-1504r02