[On using the corpses of large mammals as model objects for studying the postmortem period]. / Ob ispol'zovanii trupov krupnykh mlekopitayushchikh v kachestve model'nykh ob"ektov pri izuchenii postmortal'nogo perioda.

THE AIM OF THE STUDY: Is to justify using the corpses of large mammals as model objects for studying the postmortem period. Similarities in processes occurring postmortem in human and swine corpses (decomposition stages and the structure of dominant necrophilic organisms inhabiting the corpse), as well as similar changes of relative impedance parameters for the cartilaginous tissue and musculoskeletal flap of swine and human corpses have been established. The results obtained allow recommending the swine corpse as an adequate human corpse model both for scientific studies and for solving specific scientific and practical issues arising in the practice of forensic examination when determining the prescription of death coming and the postmortem period conditions.

Modelling changes in healthcare demand through geographic data extrapolation.

Stay Well Plans are a new programme of care offered to frail and elderly people in Newport. In 2016 a roll out the programme to be offered in all five counties serviced by Aneurin Bevan University Health Board was planned. This paper presents the data analysis and modelling used to determine the programme's effects on the demand of the wider system, and the effects of a Gwent-wide roll out. We extrapolate information from data from a geographical subset of the model domain to a larger geographical area, adjusting for population sizes, deprivation, and distances to healthcare facilities. These parametrise a Markov model and Monte Carlo simulation to predict changes in demand due to different levels of roll out. We conclude that a programme roll out may result in a large reduction on demand at residential care, however at the expense of an increase in demand at community care services.

[The Exploration of Extrapolation of Data from Adults to Pediatric Population].

Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.

The Exploration of Extrapolation of Data from Adults to Pediatric Population / 中国医疗器械杂志

Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.

Macromolecule mapping of the brain using ultrashort-TE acquisition and reference-based metabolite removal.

PURPOSE: To develop a practical method for mapping macromolecule distribution in the brain using ultrashort-TE MRSI data. METHODS: An FID-based chemical shift imaging acquisition without metabolite-nulling pulses was used to acquire ultrashort-TE MRSI data that capture the macromolecule signals with high signal-to-noise-ratio (SNR) efficiency. To remove the metabolite signals from the ultrashort-TE data, single voxel spectroscopy data were obtained to determine a set of high-quality metabolite reference spectra. These spectra were then incorporated into a generalized series (GS) model to represent general metabolite spatiospectral distributions. A time-segmented algorithm was developed to back-extrapolate the GS model-based metabolite distribution from truncated FIDs and remove it from the MRSI data. Numerical simulations and in vivo experiments have been performed to evaluate the proposed method. RESULTS: Simulation results demonstrate accurate metabolite signal extrapolation by the proposed method given a high-quality reference. For in vivo experiments, the proposed method is able to produce spatiospectral distributions of macromolecules in the brain with high SNR from data acquired in about 10 minutes. We further demonstrate that the high-dimensional macromolecule spatiospectral distribution resides in a low-dimensional subspace. This finding provides a new opportunity to use subspace models for quantification and accelerated macromolecule mapping. Robustness of the proposed method is also demonstrated using multiple data sets from the same and different subjects. CONCLUSION: The proposed method is able to obtain macromolecule distributions in the brain from ultrashort-TE acquisitions. It can also be used for acquiring training data to determine a low-dimensional subspace to represent the macromolecule signals for subspace-based MRSI. Magn Reson Med 79:2460-2469, 2018. © 2017 International Society for Magnetic Resonance in Medicine.

Product Development Under FDA's Animal Rule: Understanding FDA's Expectations and Potential Implications for Traditional Development Programs.

In 2002 the US Food and Drug Administration (FDA) established a regulatory pathway for drug and biological products targeting indications for which human efficacy studies are not feasible or ethical. These regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the "Animal Rule," were the result of many years of thinking about how to make such products available to people who might need them. A handful of products have been approved under the Animal Rule, and several others are in development. This article reviews how different products met the requirements for licensure under the Animal Rule, based on information publicly available on FDA's website. The primary aim of this manuscript is to offer an understanding of FDA's interpretation of relevant regulations and guidances in the context of this licensure pathway. Some of the methods used for Animal Rule approvals may also have potential application in more traditional development programs. Thus, this article may also offer insight into methods for accelerating product development in general.