Nontraditional Study Designs for Proving Bioequivalence

Proving Hardware Designs

Vhdl is a standardized hardware description language with almost universal market penetration. Originally developed in the 1980s with the support of the US DoD, several formalizations of its hardware simulation semantics have appeared in the last few years, including operational semantics in higher order logic and translations to Petri Nets and finite state machines. But in recent work [1] we h...

Individual bioequivalence testing under 2x3 designs.

In recent years, as more generic drug products become available, it is a concern not only whether generic drug products that have been approved based on the regulation of average bioequivalence will have the same quality, safety and efficacy as that of the brand-name drug product, but also whether the approved generic drug products can be used interchangeably. In its recent draft guidance, the ...

On Proving Sequential Machine Designs

Establishing bioequivalence in complete and incomplete data designs using AUCs.

Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in humans. The drug exposure in animal studies is often measured by the area under the concentration versus time curve (AUC). The classical complete data design where each animal is sampled for analysis at every time point is applicable for large animals only. In th...

Pharmacokinetic studies for proving bioequivalence of orally inhaled drug products—critical issues and concepts

The inhalational drug market, especially the generic market, has a tremendous growth potential globally (GBI Research, 2011; Espicom, 2013; Transperancy: Market Research, 2013). Generics are drugs that are bioequivalent to the approved drugs. The United States Food and Drug Administration (FDA) has defined bioequivalence as (U.S. FDA, 2014), “The absence of a significant difference in the rate ...