Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs. A study is performed to evaluate the single- dose pharmacokinetic bioequivalence of 2 (1 branded drug and 1 generic drug) on- market, immediate-release lamotrigine drug products. The Equivalence Among Antiepileptic Drug Generic and Brand Products in People with Epilepsy (EQUIGEN) single-dose study is a crossover, prospective, sequence-randomized, replicate pharmacokinetic study conducted at 5 US academic epilepsy centers. Fifty adults (218 years) with epilepsy who were taking concomitant antiepileptic drugs and not currently receiving lamotrigine were enrolled and every participant was randomly assigned to 1 of 2 equivalent sequences, each comprising 6 study periods, during which they had blood draws before and after medication administration. The primary outcome was bioequivalence between products as measured by the maximum plasma concentration (Cmax). A. With respect to hypothesis testing, what type of study would best describe this study? I. Superiority (or difference) study II. Equivalence study III. Non-inferiority study B. What are the null and alternative hypotheses? It is okay to describe the hypotheses in words.

MATLAB: An Introduction with Applications

6th Edition

ISBN:9781119256830

Author:Amos Gilat

Publisher:Amos Gilat

Chapter1: Starting With Matlab

Section: Chapter Questions

Problem 1P

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Transcribed Image Text:Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs. A study is performed to evaluate the single- dose pharmacokinetic bioequivalence of 2 (1 branded drug and 1 generic drug) on- market, immediate-release lamotrigine drug products. The Equivalence Among Antiepileptic Drug Generic and Brand Products in People with Epilepsy (EQUIGEN) single-dose study is a crossover, prospective, sequence-randomized, replicate pharmacokinetic study conducted at 5 US academic epilepsy centers. Fifty adults (218 years) with epilepsy who were taking concomitant antiepileptic drugs and not currently receiving lamotrigine were enrolled and every participant was randomly assigned to 1 of 2 equivalent sequences, each comprising 6 study periods, during which they had blood draws before and after medication administration. The primary outcome was bioequivalence between products as measured by the maximum plasma concentration (Cmax). A. With respect to hypothesis testing, what type of study would best describe this study? I. Superiority (or difference) study II. Equivalence study III. Non-inferiority study B. What are the null and alternative hypotheses? It is okay to describe the hypotheses in words.

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Equivalence is best described because in the given question bioequivalence have to be checked.

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