School Nutrition Director Perceptions of Flexible Regulations for School Nutrition Programs in One Southeastern State.

BACKGROUND: Schools are a promising site for influencing the dietary intake of children and adolescents. The US Department of Agriculture recently released flexibilities to requirements for whole-grains, sodium, and low-fat milk in schools who demonstrated difficulty meeting nutrition standards for school meal programs. The support of School Nutrition Directors (SNDs) is vital to the success of school food environment changes; however, few studies have explored SNDs perceptions to changes in nutrition standards. METHODS: Experiences and perspectives toward nutrition standards of 10 SNDs, and their satisfaction with flexibilities for whole-grains, sodium, and low-fat milk were explored using a semi-structured interview. Responses were analyzed using an inductive approach with thematic analysis. RESULTS: Three broad categories emerged challenges with the Healthy, Hunger-Free Kids Act, food preferences and acceptability, and support and representation. A greater need for internal and external support, assistance in equipment and staff, procurement of foods compliant with regulations and acceptable to students, and more input on federal decisions and policies were perceived as important. CONCLUSIONS: Results provide critical insight into the implementation of nutrition standards. Future research and changes to school nutrition programs should consider these challenges as they strive to meet the needs of this important population.

Governança global, regulamentação flexível e os ensaios clínicos na medicina regenerativa no Reino Unido e na União Europeia / Global Governance, Flexible Regulation and Clinical Trials in Regenerative Medicine in the United Kingdom and the European Union

Resumo A medicina regenerativa encontra-se em fase de desenvolvimento dos ensaios clínicos em terapias celulares (TC), na sua manufatura e na sua adoção gradual dentro dos sistemas de saúde. Entretanto, há uma série de lacunas e contradições na governança e regulamentação na área e o objetivo principal deste artigo é sua discussão dentro das tendências globais, já que esses processos afetam de modo substantivo a saúde coletiva global e encontram-se ainda escassamente resolvidos. O texto foca nos processos prevalentes nos ensaios clínicos com TC em duas lideranças internacionais, o Reino Unido e a União Europeia, utilizando a análise bibliográfica e de conteúdo. O texto conclui com uma discussão das principais vantagens e desvantagens para a saúde coletiva global da transição de um modelo científico de comprovação das novas terapias celulares para, eventualmente, outro baseado na inovação médica ou clínica. O último procede desde a fase pré-clínica com animais à aplicação das novas terapias a grupos pequenos de pacientes e, logo a seguir, a sua inserção no mercado. Muitas vezes, esse modelo se associa a flexibilidades regulatórias, a serem ilustradas no artigo, e especialmente desenhadas para aumentar a rapidez no desenvolvimento e aplicação das terapias.

Abstract Regenerative medicine is at present in a stage of development of clinical trials in cell therapies (CT), their manufacture and gradual adoption by health systems. However, there are several gaps and contradictions in governance and regulation in the area and the main aim of this article is their discussion within global trends, as these processes remain still ill- resolved while substantively affecting collective global health. The text focuses on an analysis of prevailing processes in clinical trials with CT by two leading actors, the United Kingdom, and the European Union, and is based upon bibliographical and content analyses. The article concludes with a discussion of the main advantages and disadvantages for collective global health of the transition from a conventional scientific model to test the new therapies to, eventually, one based on medical or clinical innovation. The latter proceeds from the pre-clinical research phase with animals to clinical trials with small groups of patients and subsequently, to the entrance of cell therapies into the market. Often this model is associated to flexible regulations, to be illustrated in the article, which are specifically designed to diminish time-lags between therapy development and its full application.

Exploration and Preparation of a Dose-Flexible Regulation System for Levetiracetam Tablets via Novel Semi-Solid Extrusion Three-Dimensional Printing.

Levetiracetam therapy is often associated with high levels of individual variation in the recommended dose required to achieve preferential treatment. Thus, a reliable and dynamic regulation system to accurately tailor dose is necessary. The main objective of this study is to explore and prepare a dose-flexible control system suitable for rapid release tablets equipped with high drug loading and a cylindrical model design. Semi-solid extrusion 3-dimensional printing was utilized to fabricate a series of tablets of increased volume. This method was compatible with 3 patterns to regulate the volumes to manipulate the tablet mass and achieve tailored personalized precision dosing. All tablets from each pattern exhibited a smooth surface and regular shape, as well as sufficient mechanical strength. A good linear correlation between the mass and theoretical volume of the tablets was maintained, regardless of the pattern used. The range of dose accuracy was between 103.3% and 96.2%, with an acceptable variation coefficient in the range of 0.6%-3.2%. Faster release behavior for levetiracetam can be achieved from the small-sized tablets due to their larger surface area/mass ratio. All the results demonstrated the potential and capability of semi-solid extrusion 3-dimensional printing as a novel pharmaceutical manufacturing technique to provide a dynamic and highly accurate controllable system for preparing patient-tailored medicines.