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Pharmaceutical & Medical Packaging News, November/December 2014

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11 November/December 2014 Pharmaceutical & Medical Packaging News • Pharmaceutical packaging engi- neers should "really be aware of these definitions and how they apply to oth- er chapters," says Hunt. The chapter also consolidates all definitions for packages, storage, and distribution. "We also expect it will lead to revi- sions in other chapters," he says. USP Chapter <381> Elastomer- ic Closures for Injections is also up for revision. "We've just formed an Expert Panel, says Hunt; and they will be working towards modernizing the chapter," he adds. USP is also looking to modernize Chapter <660> Containers—Glass, which covers glass durability, says Hunt. USP works closely with FDA in the development and revision of chapters, with a liaison from FDA sitting on the Expert Panels and Expert Committee. Questions about USP's chapters can be sent directly to Dr. Desmond Hunt at The Role of Functional Equivalence Analysis in the DuPont Tyvek Medical Packaging Transition Project P ackage testing for the DuPont Tyvek Medical Packaging Transi- tion Project (MPTP) is progressing on schedule, and all results published to date support the functional equiva- lence of the transitional material to the current Tyvek. While testing con- tinues, DuPont expects that the U.S. FDA will afrm functional equivalence by the third quarter 2015. Medical device manufacturers close- ly following the MPTP may wonder why DuPont is conducting functional equivalence analysis rather than sta- tistical significance analysis, especially if the MDM is accustomed to running statistical significance testing. In the recent webinar, "The Results Are In – But What Can I Do with Them?" members of the MPTP team defined functional equivalence test- ing and why they chose such analy- sis. Jennifer H. Van Mullekom, Ph.D., DuPont's senior consulting statistician who has been working on the project since 2009, explained the statistical approach; Leslie Love, MDM Special- ist, provided an update on MPTP tim- ing and then moderated a discussion with Van Mullekom and Mike Scholla, Ph.D., Global Regulatory Director, to cover some of the frequently asked questions DuPont has received during the project. Van Mullekom explained that the U.S. FDA's ofcial guidance was to use functional equivalence testing. "Equivalence testing was a technique that's been used in the drug indus- try for the last 25 to 30 years," she said. "One of the applications is in the area of ensuring equivalent per- formance for a brand name and a generic drug." To illustrate the diference between functional equivalence and statisti- cal significance and what functional equivalence means for the MPTP, Van Mullekom compared the proj- ect to landing an airplane on a run- way. "The airplane will serve as our Transition Tyvek protocol material in this analogy," she said. "The cen- terline of the runway is like the cur- rent Tyvek material. The edges of the runway are like our functional equivalence bounds. We are trying to land our airplane on the center- line but realizing there may be some error so we need to think about get- ting our plane on the runway." To see this analogy in action, please watch the on-demand Webcast at www. "Let's consider what would hap- pen if we wrote our study design and required that the Transition Material have no significant diference from the current Tyvek," she continued. "That would be like saying that the airplane, which represents the Transition Mate- rial, has to be perfectly lined up with the current Tyvek material every time. The airplane would have to land on the centerline every single time. That would create criteria that are virtually impossible to achieve in every single instance. "Functional equivalence acknowl- edges the 'noise factors' that contrib- ute to typical process variability," Van Mullekom continued. "In the process of sealing a package, these might be equipment maintenance cycles, film batches, ambient tem- perature, humidity, and even Tyvek batch-to-batch variability. Function- al equivalence allows us to land our plane, the Transition Tyvek Mate- rial, on the runway but does not penalize us if we are right or left of center. We just have to stay on the runway." F u n c t i o n a l e q u i v a l e n c e t e s t - i n g e m p l o y s t h e s a m e s t a t i s t i c a l technique as statistical significance testing, but users just interpret the results differently, Van Mullekom said. "For statistical significance test- ing you are going to have a 95% confidence interval. For functional equivalence testing you have a 90% confidence interval." Acknowledg- ing that some MDMs may question whether "the 90% confidence inter- val maintains the Type I error rate at 5%," she said that there are "quite a few statistical references" to support that claim. She did emphasize that statistical significance testing "can- not prove that two groups are the same." It has "limitations," she said, and "can only prove that two groups are diferent. Functional equivalence testing is the only technique that can prove that two groups are the same within a prespecified margin."

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