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  • Title: Meta-analysis for bioequivalence review.
    Author: Chow SC, Liu J.
    Journal: J Biopharm Stat; 1997 Mar; 7(1):97-111. PubMed ID: 9056591.
    Abstract:
    The problem of drug interchangeability among a brand-name drug and its generic copies is considered. Under current Food and Drug Administration (FDA) regulation, a patient may switch from the brand-name drug to a generic drug if the generic drug is shown to be bioequivalent to the brand-name drug based on bioequivalence testing. After the patent of a brand-name drug is expired, usually there will be a number of generic copies available on the market. The FDA does not indicate that a patient may switch from a generic to another even though both of the generic drugs are bioequivalent to the brand-name drug. As a result, drug interchangeability among the brand-name and its generic copies is a safety concern. In this paper, we propose to perform a meta-analysis for an overview of bioequivalence. The proposed meta-analysis provides an assessment of bioequivalence among generic copies of a brand-name that can be used as a tool to monitor the performance of the approved generic copies of the brand-name drug. In addition, it provides more accurate estimates of inter- and intrasubject variabilities of the drug product.
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