Bioequivalence trial with two generic drugs in 2 × 3 crossover design with missing data
نویسندگان
چکیده
منابع مشابه
Bioequivalence of generic drugs.
Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy o...
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To evaluate globally the average bioequivalence of a test drug to a reference drug in a pharmacokinetic (PK) study under a 2 x 2 crossover design, we consider directly comparing the associated drug concentration-time curves. Statistical models for the drug concentrations are suggested when the concentrations measured at different time points are distributed according to a generalized gamma dist...
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In the classical data envelopment analysis (DEA) models, inputs and outputs are assumed as known variables, and these models cannot deal with unknown amounts of variables directly. In recent years, there are few researches on handling missing data. This paper suggests a new interval based approach to apply missing data, which is the modified version of Kousmanen (2009) approach. First, the prop...
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Sequential design is an adaptive design that allows for pre-mature termination of a trial due to efficacy or futility based on the interim analyses. The concept of sequential statistical methods was originally motivated by the need to obtain clinical benefits under certain economic constraints. That is for a trial for a positive results, early stopping ensures that a new drug product can exploi...
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BACKGROUND Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokin...
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ژورنال
عنوان ژورنال: Communications for Statistical Applications and Methods
سال: 2020
ISSN: 2383-4757
DOI: 10.29220/csam.2020.27.6.641