Statistical and Regulatory Considerations for Multiple Measures in Bioequivalence Testing

AbstractRegulations for approval of new generic pharmaceutical products often involve multiple requirements. for example, most countries include requirements for both total and peak exposures to the drug (AUC and CMAX) to be approved, the new product must satisfy all requirements. This is a “joint decision rule.” the statistical properties of a joint decision rule depend on the nature of the criteria associated with the individual requirements. the effect of a joint rule may be to reduce the consumer risk below the nominal (and typically quoted) 5% that applies to each requirement on its own. the focus of this paper is on the issues related to the development of joint decision rules for bioequivalence that constrain the consumer risk while minimizing the producer risk.