PolymerPlus (United States)

High-field electric poling locks impurity ions at interfaces in multilayer polymer films, which enhances dielectric insulation and reduces ionic conduction loss for electric energy storage applications.

Genetic Engineering & Biotechnology NewsVol. 37, No. 7 Bioprocessing TutorialSimplifying the Efficient Clinical-Grade Production of VirusesOne-Size-Fits-All Transfection Reagent, From Process Development to GMP-grade ProductionAlengo Nyamay’Antu, Valérie Kédinger, and Patrick ErbacherAlengo Nyamay’AntuAlengo Nyamay’Antu, Ph.D., is scientific and technical support specialist; Valérie Kédinger, Ph.D., is GMP application specialist; and Patrick Erbacher, Ph.D., is CSO at Polyplus-transfection. Website: www.polyplus-transfection.com.Search for more papers by this author, Valérie KédingerAlengo Nyamay’Antu, Ph.D., is scientific and technical support specialist; Valérie Kédinger, Ph.D., is GMP application specialist; and Patrick Erbacher, Ph.D., is CSO at Polyplus-transfection. Website: www.polyplus-transfection.com.Search for more papers by this author, and Patrick ErbacherAlengo Nyamay’Antu, Ph.D., is scientific and technical support specialist; Valérie Kédinger, Ph.D., is GMP application specialist; and Patrick Erbacher, Ph.D., is CSO at Polyplus-transfection. Website: www.polyplus-transfection.com.Search for more papers by this authorPublished Online:29 Mar 2017https://doi.org/10.1089/gen.37.07.13AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 37Issue 7Apr 2017 InformationCopyright © GEN PublishingTo cite this article:Alengo Nyamay’Antu, Valérie Kédinger, and Patrick Erbacher.Simplifying the Efficient Clinical-Grade Production of Viruses.Genetic Engineering & Biotechnology News.Apr 2017.24-25.http://doi.org/10.1089/gen.37.07.13Published in Volume: 37 Issue 7: March 29, 2017PDF download

A nanolayered polymer films fabrication approach creating Gradient Refractive INdex (GRIN) lenses with designer RI distribution profiles is reviewed. Fabricated GRIN examples are presented demonstrating unparalleled RI profile design freedom and scalable optic size.

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 U.S. Food and Drug Administration (FDA) recommends that individual bioequivalence (IBE) be assessed using the method proposed by Hyslop, Hsuan, and Holder to address drug switchability. The FDA suggests that a 2x4 cross-over design be considered for assessment of IBE, while a 2x3 cross-over design may be used as an alternative design to reduce the length and cost of the study. Little or no information regarding the statistical procedures under 2x3 cross-over designs is discussed in the guidance. In this paper, a detailed statistical procedure for assessment of IBE under 2x3 cross-over designs is derived. The main purpose of this paper, however, is to derive an IBE test under an alternative 2x3 design and show that the resulting IBE test is better than that under a 2x3 cross-over design and is comparable to or even better than that under a 2x4 cross-over design. Our conclusions are supported by theoretical considerations and empirical results. Furthermore, a method of determining the sample sizes required for IBE tests to reach a given level of power is proposed.

One-sample and two-sample t-tests are commonly used in analyzing data from clinical trials in comparing mean responses from two drug products. During the planning stage of a clinical study, a crucial step is the sample size calculation, i.e., the determination of the number of subjects (patients) needed to achieve a desired power (e.g., 80%) for detecting a clinically meaningful difference in the mean drug responses. Based on noncentral t-distributions, we derive some sample size calculation formulas for testing equality, testing therapeutic noninferiority/superiority, and testing therapeutic equivalence, under the popular one-sample design, two-sample parallel design, and two-sample crossover design. Useful tables are constructed and some examples are given for illustration.

Unlike most drug products, some drug products must be stored at several temperatures, such as -20 degrees C, 5 degrees C and 25 degrees C, in order to maintain the stability of the drug products. Drug products of this kind are usually referred to as frozen drug products. The determination of shelf-life for frozen drug products involves the estimation of drug shelf-lives at different temperatures, which requires multiple phase linear regression. Mellon suggested obtaining a combined shelf-life by determining shelf-lives based on data available at different temperatures. This method, however, does not account for the fact that the shelf-life at the second-phase would depend on the shelf-life at the first phase. As an alternative, we propose a method for determination of drug shelf-lives for the two phases using a two-phase regression analysis based on the statistical principle described in the FDA guideline and the ICH guideline. A numerical example is presented to illustrate the proposed method.