Meta-Analysis for Safety Monitoring of Drug Interchangeability
Wen-Wei Liu* and Shein-Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
- *Corresponding Author:
- Wen-Wei Liu, M.S.
Department of Biostatistics and Bioinformatics
Duke University School of Medicine
2424 Erwin Road, Durham, NC 27705, USA
E-mail: [email protected]
Received Date: June 25, 2015 Accepted Date: July 27, 2015 Published Date: August 08, 2015
Citation: Liu WW, Chow SC (2015) Meta-Analysis for Safety Monitoring of Drug Interchangeability. J Bioequiv Availab 7:239-243. doi:10.4172/jbb.1000247
Copyright: © 2015 Liu WW, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
When an innovative (brand-name) drug is going off patent protection, pharmaceutical or generic companies may file an abbreviated new drug application (ANDA) for generic approval. As indicated by the United States Food and Drug Administration (FDA), an approved generic drug can be used as a substitute for the brand-name drug. FDA, however, does not indicate that approved generic drugs of the same brand-name drug can be used interchangeably. As more generic drugs become available in the marketplace, it is a concern whether the approved generic drugs are safe and can be used interchangeably. In this article, we propose two safety margins as new bioequivalence limits for monitoring of drug interchangeability based on a meta-analysis of data obtained from regulatory submissions which have been approved by FDA. In addition to the monitoring of drug interchangeability of generic drugs, the proposed margins can also be extended to address drug interchangeability of biosimilars.