Cenário para Reforçar os Sistemas na Procura de Melhores Produtos da Saúde

uma oportunidade para impulsionar o desenvolvimento e o crescimento económico, contribuir para salvar milhões de vidas e evitar incapacidades ao longo da vida, aproximando os países da consecução dos objectivos das estratégias nacionais de redução da pobreza e dos Objectivos de Desenvolvimento do Milénio (ODM). Para promover um maior e melhor investimento na saúde, a Harmonização da Saúde na África concebeu o Cenário de Investimento para a África com estas finalidades: 1) ajudar os dirigentes africanos e os seus parceiros regionais e globais a centrar as atenções e os recursos num investimento profícuo em saúde; 2) dar aos Ministérios da Saúde bases factuais para convencer os Ministérios das Finanças, os parlamentos nacionais e outros intervenientes chave de que investir na saúde faz sentido do ponto de vista económico e de que terá um retorno considerável; 3) obter mais valor pelo dinheiro investido, demonstrando como a eficácia com que os recursos novos ou já existentes são injectados no sistema de saúde pode ser potenciada graças a um processo de definição de prioridades, com base nas tendências demográficas e no fardo da doença; e 4) mobilizar as lideranças, a nível nacional, regional e global, para que apoiem os sistemas nacionais de saúde da África, nos seus esforços para aumentar o ritmo e a sustentabilidade na procura de melhor saúde e maior desenvolvimento económico para as populações africanas.Harmonization For Health in África,UNICEF,USAID, The world Bank, World Health Organization,the Partnership,Jica,UNFP

PSL Icing Facility Upgrade Overview

The NASA Glenn Research Center Propulsion Systems Lab (PSL) was recently upgraded to perform engine inlet ice crystal testing in an altitude environment. The system installed 10 spray bars in the inlet plenum for ice crystal generation using 222 spray nozzles. As an altitude test chamber, the PSL is capable of simulating icing events at altitude in a groundtest facility. The system was designed to operate at altitudes from 4,000 to 40,000 ft at Mach numbers up to 0.8M and inlet total temperatures from -60 to +15 degF. This paper and presentation will be part of a series of presentations on PSL Icing and will cover the development of the icing capability through design, developmental testing, installation, initial calibration, and validation engine testing. Information will be presented on the design criteria and process, spray bar developmental testing at Cox and Co., system capabilities, and initial calibration and engine validation test. The PSL icing system was designed to provide NASA and the icing community with a facility that could be used for research studies of engine icing by duplicating in-flight events in a controlled ground-test facility. With the system and the altitude chamber we can produce flight conditions and cloud environments to simulate those encountered in flight. The icing system can be controlled to set various cloud uniformities, droplet median volumetric diameter (MVD), and icing water content (IWC) through a wide variety of conditions. The PSL chamber can set altitudes, Mach numbers, and temperatures of interest to the icing community and also has the instrumentation capability of measuring engine performance during icing testing. PSL last year completed the calibration and initial engine validation of the facility utilizing a Honeywell ALF502-R5 engine and has duplicated in-flight roll back conditions experienced during flight testing. This paper will summarize the modifications and buildup of the facility to accomplish these tests

Blood Cytokines as Biomarkers of In Vivo Toxicity in Preclinical Safety Assessment: Considerations for Their Use

In the drive to develop drugs with well-characterized and clinically monitorable safety profiles, there is incentive to expand the repertoire of safety biomarkers for toxicities without routine markers or premonitory detection. Biomarkers in blood are pursued because of specimen accessibility, opportunity for serial monitoring, quantitative measurement, and the availability of assay platforms. Cytokines, chemokines, and growth factors (here referred to collectively as cytokines) show robust modulation in proximal events of inflammation, immune response, and repair. These are key general processes in many toxicities; therefore, cytokines are commonly identified during biomarker discovery studies. In addition, multiplexed cytokine immunoassays are easily applied to biomarker discovery and routine toxicity studies to measure blood cytokines. However, cytokines pose several challenges as safety biomarkers because of a short serum half-life; low to undetectable baseline levels; lack of tissue-specific or toxicity-specific expression; complexities related to cytokine expression with multiorgan involvement; and species, strain, and interindividual differences. Additional challenges to their application are caused by analytical, methodological, and study design–related variables. A final consideration is the strength of the relationship between changes in cytokine levels and the development of phenotypic or functional manifestations of toxicity. These factors should inform the integrated judgment-based qualification of novel biomarkers in preclinical, and potentially clinical, risk assessment. The dearth of robust, predictive cytokine biomarkers for specific toxicities is an indication of the significant complexity of these challenges. This review will consider the current state of the science and recommendations for appropriate application of cytokines in preclinical safety assessment

Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo

<p>Abstract</p> <p>Background</p> <p>Many patients with diabetes mellitus (DM) require a combination of antidiabetic drugs with complementary mechanisms of action to lower their hemoglobin A_1clevels to achieve therapeutic targets and reduce the risk of cardiovascular complications. Linagliptin is a novel member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of antidiabetic drugs. DPP-4 inhibitors increase incretin (glucagon-like peptide-1 and gastric inhibitory polypeptide) levels, inhibit glucagon release and, more importantly, increase insulin secretion and inhibit gastric emptying. Currently, phase III clinical studies with linagliptin are underway to evaluate its clinical efficacy and safety. Linagliptin is expected to be one of the most appropriate therapies for Japanese patients with DM, as deficient insulin secretion is a greater concern than insulin resistance in this population. The number of patients with DM in Japan is increasing and this trend is predicted to continue. Several antidiabetic drugs are currently marketed in Japan; however there is no information describing the effective dose of linagliptin for Japanese patients with DM.</p> <p>Methods</p> <p>This prospective, randomized, double-blind study will compare linagliptin with placebo over a 12-week period. The study has also been designed to evaluate the safety and efficacy of linagliptin by comparing it with another antidiabetic, voglibose, over a 26-week treatment period. Four treatment groups have been established for these comparisons. A phase IIb/III combined study design has been utilized for this purpose and the approach for calculating sample size is described.</p> <p>Discussion</p> <p>This is the first phase IIb/III study to examine the long-term safety and efficacy of linagliptin in diabetes patients in the Japanese population.</p> <p>Trial registration</p> <p>Clinicaltrials.gov (NCT00654381).</p

Scientific Opinion on safety and efficacy of hydroxy-analogue of selenomethionine as feed additive for all species

The additive hydroxy-analogue of selenomethionine consists of synthetic R,S-2-hydroxy-4-methylselenobutanoic acid (HMSeBA) and is intended to be used as a source of the essential trace element selenium for all animal species/categories. Based on data from tolerance studies in chickens and turkeys for fattening and piglets, the additive is considered as safe for all species/categories up to the maximum authorised total selenium level in complete feed. After being absorbed, HMSeBA is metabolised to selenomethionine; consequently, no residues of the compound itself occur in animal tissues and products. Compared with inorganic selenium sources, the use of HMSeBA in animal nutrition would result in a similar increase in selenium deposition in animal tissues/products as that resulting from selenised yeast. To ensure consumer safety from consumption of food originating from animals supplemented with HMSeBA, the FEEDAP Panel concluded that selenium supplementation from the additive should not exceed a maximum of 0.2 mg Se/kg complete feed. The additive should be regarded as an eye irritant, but should not be classified as skin irritant or skin sensitiser. Inhalation exposure poses a hazard to users; the FEEDAP Panel concludes, therefore, that the formulation and conditions of use of the solid form of the additive should minimise user exposure by inhalation. The use of HMSeBA in feed does not pose an additional risk to the environment, compared to other sources of selenium for which it will substitute, as long as the maximum authorised content in feedingstuffs is not exceeded. Based on the response of plasma glutathione peroxidase activity and the plasma/liver concentration of selenium in chickens for fattening and pigs for fattening, the FEEDAP Panel considers that HMSeBA is an efficaceous source of selenium for all animal species/categories. HMSeBA does not modify the quality of meat as measured by physico-chemical properties

Potential of NIR spectroscopy to predict amygdalin content established by HPLC in intact almonds and classification based on almond bitterness

[EN] In this study, 360 intact almonds, half sweet and half bitter, were assessed by near-infrared (NIR) spectroscopy to predict amygdalin content (established by high performance liquid chromatography (HPLC)) and by applying partial least squares (PLS) to the spectral data. After optimising amygdalin extraction and chromatographic conditions, the amygdalin contents found by HPLC were not detected or below to 350 mg kg-1 for sweet almonds, and between 14,700 and 50,400mg kg 1 for bitter almonds. The intact almond spectra resulted in good predictions of amygdalin content with R2p of 0.939 and RMSEP of 0.373. Almonds were correctly classified into sweet and bitter by linear discriminant analysis (LDA), quadratic discriminant analysis (QDA) and PLS-DA, with sensitivity and specificity values higher than 0.94 for evaluation set samples. Based on these results, it can be concluded that NIR spectroscopy is a good non-destructive alternative to be used as an automatic in-line classification system by food industry.Victoria Cortes Lopez thanks the Spanish Ministry of Education, Culture and Sports for the FPU grant (FPU13/04202). The authors wish to thank the cooperative Agricoop for kindly donating the almonds.Cortes-Lopez, V.; Talens Oliag, P.; Barat Baviera, JM.; Lerma-García, MJ. (2018). Potential of NIR spectroscopy to predict amygdalin content established by HPLC in intact almonds and classification based on almond bitterness. Food Control. 91:68-75. https://doi.org/10.1016/j.foodcont.2018.03.040S68759

Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use

<p>Abstract</p> <p>Background</p> <p>The objective of this work was to study the vitamins B₁, B₂, B₆and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulfate, pediatric vitamins and trace elements under different conditions using developed and validated analytical methods.</p> <p>Methods</p> <p>The study was carried out during 72 h with formulations packaged in recommended storage temperature (4°C) and 25°C, with and without photoprotection.</p> <p>Results</p> <p>The results showed that the methodologies used for assessing the chemical stability of vitamins B₁, B₂, B₆and C in the formulation were selective, linear, precise and accurate. The vitamins could be considered stable in the formulation during the three days of study if stored at 4°C. When stored at 25°C vitamin C presented instability after 48 h.</p> <p>Conclusion</p> <p>The pediatric formulation containing high amount of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulphate, pediatric vitamins and trace elements packaged in bag-type trilaminate presented a shelf life of the 72 h, when maintained under refrigeration, between 2°C and 8°C. This shelf life was measured considering the vitamins studied. Further studies are needed including all the vitamins present in this formulation.</p