Meta-analysis for bioequivalence review.

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.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics