New Bioequivalence Studies : Individual Bioequivalence and Population Bioequivalence
نویسندگان
چکیده
منابع مشابه
Statistical Tests for Population Bioequivalence
In its 2001 guidance, the U.S. Food and Drug Administration (FDA) recommends that population bioequivalence (PBE) and individual bioequivalence (IBE) be assessed to address respectively the prescribability and switchability between a brand-name drug product and its new formulation or generic copy. For IBE, the FDA recommends a 2×4 crossover design and a statistical test procedure proposed by Hy...
متن کاملTesting Population and Individual Bioequivalence: A Hierarchical Bayesian Approach
The US Food and Drug Administration has recommended statistical guidelines that introduce two new bioequivalence criteria: population bioequivalence (PBE) and individual bioequivalence (IBE). In this paper we propose a hierarchical Bayesian methodology for evaluating these recently introduced criteria. We derive the joint posterior distribution of the parameters involved in a crossover design a...
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...
متن کاملA Note on an Individual Bioequivalence Setting
We give a new simpler proof along with a generalization for the inequality of Yao and Iyer [10] arising in bioequivalence studies and by using a nonparametric approach we also discuss an extension of the individual bioequivalence setting to the case where the data are not necessarily normally distributed.
متن کاملذخیره 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: YAKUGAKU ZASSHI
سال: 2000
ISSN: 0031-6903,1347-5231
DOI: 10.1248/yakushi1947.120.11_1201