Within the scope of this research, a new short-time procedure designated as StressLifeHCF was developed. Through a combination of classic fatigue testing and non-destructive monitoring of the material response due to cyclic loading, a process-oriented fatigue life determination can be carried out. A total of two load increases and two constant amplitude tests are required for this procedure.
View Article and Find Full Text PDFTensile tests and fatigue tests on differently heat-treated low carbon (non- and low-alloy) steels were conducted and accompanied by non-destructive electrical resistometric (ER) and magnetic Barkhausen noise (MBN) measuring devices, in order to establish an improved short-time fatigue life estimation method according to StressLife. MaRePLife (terial sponse artitioning) is the hereby proposed method for calculating S-N curves in the HCF regime, based on the partitioning of material responses acquired during the above-mentioned mechanical tests. The rules were set to make use of the information gathered from pre-conducted tensile tests, which helps to determine the parameters of two load increase tests (LIT) and two constant amplitude tests (CAT).
View Article and Find Full Text PDFJ Aerosol Med Pulm Drug Deliv
December 2017
Background: Multiple factors may influence the performance of a metered dose inhaler (MDI) when used with a valved holding chamber (VHC or "spacer").
Methods: Andersen Cascade Impactor measurements were conducted for three MDI products and two different VHCs using a specially designed system that accommodated variable delay times between MDI actuation and introduction of the aerosol into the impactor, and allowed reduced flow through the VHC while the impactor was operated at 28.3 L/min.
J Allergy Clin Immunol
January 2015
Objectives: In 1994, the US Food and Drug Administration (FDA) proposed an approach, based on extrapolation of efficacy findings from adults to the pediatric population, to maximize the use of adult data and other data when designing pediatric drug-development programs. We examined the experience of the FDA in using extrapolation to evaluate how and when it was used and any changes in scientific assumptions over time.
Methods: We reviewed 370 pediatric studies submitted to the FDA between 1998 and 2008 in response to 159 written requests (166 products) issued under the Pediatric Exclusivity Provision.
J Health Polit Policy Law
August 2010
The literature on the causes of health care reform is dominated by institutionalist accounts, and political institutions are among the most prominent factors cited to explain why change takes place. However, institutionalist accounts have difficulty explaining both the timing and the content of reforms. By applying a range of explanatory approaches to a case study of health reform in New Zealand since the 1970s, this article explores some of the theories of reform beyond institutionalism, particularly those that take into account problem pressure, policy ideas, and the more agency-centered factor of partisan ideology.
View Article and Find Full Text PDFBackground: Risk of anaphylaxis is included in the prescribing information for omalizumab, but the nature of these reactions merits further elaboration.
Objective: To describe cases of anaphylaxis associated with omalizumab administration in patients with asthma.
Methods: We reviewed spontaneous postmarketing adverse event reports submitted to the US Food and Drug Administration's Adverse Event Reporting System database and to the manufacturers of omalizumab and cases published in the literature through December 2006.