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https://www.readbyqxmd.com/read/28445611/equivalence-of-complex-drug-products-advances-in-and-challenges-for-current-regulatory-frameworks
#1
Leonie Hussaarts, Stefan Mühlebach, Vinod P Shah, Scott McNeil, Gerrit Borchard, Beat Flühmann, Vera Weinstein, Sesha Neervannan, Elwyn Griffiths, Wenlei Jiang, Elena Wolff-Holz, Daan J A Crommelin, Jon S B de Vlieger
Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U...
April 26, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28445513/dietary-patterns-and-all-cause-cancer-and-cardiovascular-disease-mortality-in-japanese-men-and-women-the-japan-public-health-center-based-prospective-study
#2
Akiko Nanri, Tetsuya Mizoue, Taichi Shimazu, Junko Ishihara, Ribeka Takachi, Mitsuhiko Noda, Hiroyasu Iso, Shizuka Sasazuki, Norie Sawada, Shoichiro Tsugane
OBJECTIVE: A meta-analysis showed an inverse association of a prudent/healthy dietary pattern with all-cause mortality and no association of a western/unhealthy dietary pattern. However, the association of distinctive dietary patterns of Japanese population with mortality remains unclear. We prospectively investigated the association between dietary patterns and all-cause, cancer, and cardiovascular disease mortality among Japanese adults. METHODS: Participants were 36,737 men and 44,983 women aged 45-74 years who participated in the second survey of the Japan Public Health Center-based Prospective Study (1995-1998) and who had no history of serious disease...
2017: PloS One
https://www.readbyqxmd.com/read/28445490/the-effect-of-swimming-exercise-on-adenine-induced-kidney-disease-in-rats-and-the-influence-of-curcumin-or-lisinopril-thereon
#3
Badreldin H Ali, Turan Karaca, Yousuf Al Suleimani, Mohammed Al Za'abi, Jamila Al Kalbani, Mohammed Ashique, Abderrahim Nemmar
Patients with chronic kidney disease (CKD) have been reported to benefit from different types of exercises. It has also been shown that the ACE inhibitor lisinopril, and the natural product curcumin are also beneficial in different models of CKD in rats. We assessed the influence of moderate swimming exercise (SE) on rats with adenine-induced CKD, and tested the possible effects of lisinopril and/or curcumin thereon using several physiological, biochemical, histopathological and immunohistochemical parameters...
2017: PloS One
https://www.readbyqxmd.com/read/28445415/bioactive-peptides
#4
REVIEW
Eric Banan-Mwine Daliri, Deog H Oh, Byong H Lee
The increased consumer awareness of the health promoting effects of functional foods and nutraceuticals is the driving force of the functional food and nutraceutical market. Bioactive peptides are known for their high tissue affinity, specificity and efficiency in promoting health. For this reason, the search for food-derived bioactive peptides has increased exponentially. Over the years, many potential bioactive peptides from food have been documented; yet, obstacles such as the need to establish optimal conditions for industrial scale production and the absence of well-designed clinical trials to provide robust evidence for proving health claims continue to exist...
April 26, 2017: Foods (Basel, Switzerland)
https://www.readbyqxmd.com/read/28445408/algal-proteins-extraction-application-and-challenges-concerning-production
#5
REVIEW
Stephen Bleakley, Maria Hayes
Population growth combined with increasingly limited resources of arable land and fresh water has resulted in a need for alternative protein sources. Macroalgae (seaweed) and microalgae are examples of under-exploited "crops". Algae do not compete with traditional food crops for space and resources. This review details the characteristics of commonly consumed algae, as well as their potential for use as a protein source based on their protein quality, amino acid composition, and digestibility. Protein extraction methods applied to algae to date, including enzymatic hydrolysis, physical processes, and chemical extraction and novel methods such as ultrasound-assisted extraction, pulsed electric field, and microwave-assisted extraction are discussed...
April 26, 2017: Foods (Basel, Switzerland)
https://www.readbyqxmd.com/read/28445381/regulatory-advocacy-update-american-society-of-plastic-surgeons-comments-in-response-to-the-u-s-food-and-drug-administration-draft-guidance-documents-on-human-cell-and-tissue-products
#6
J Peter Rubin, Richard A D'Amico, Ricardo Rodriguez, Sydney R Coleman, Paul Cederna, Scot Glasberg, Michael Neumeister, David H Song, Charles Butler, Keith M Hume
The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.
May 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/28444877/identification-and-measurement-of-staphylococcal-enterotoxin-m-sem-from-staphylococcus-aureus-isolate-associated-with-staphylococcal-food-poisoning
#7
Yanying Zhao, Anni Zhu, Junni Tang, Cheng Tang, Juan Chen
Staphylococcus aureus (S. aureus) produces a wide variety of staphylococcal enterotoxins (SEs, SEA to SEX), which are responsible for staphylococcal food poisoning. This study is aimed to establish a system to detect SEM protein in food matrixes. In the present study, sem gene was characterized in a S. aureus isolate H4 associated with food poisoning. The amino acid sequence of the deduced SEM protein was same as that of previously identified SEM from S. aureus 04-02981. Subsequently, mature SEM protein was expressed in E...
April 26, 2017: Letters in Applied Microbiology
https://www.readbyqxmd.com/read/28444804/effect-of-resistant-starch-on-the-intestinal-health-of-old-dogs-fermentation-products-and-histological-features-of-the-intestinal-mucosa
#8
M C Peixoto, É M Ribeiro, A P J Maria, B A Loureiro, L G di Santo, T C Putarov, F N Yoshitoshi, G T Pereira, L R M Sá, A C Carciofi
The effects of resistant starch (RS) intake on nutrient digestibility, microbial fermentation products, faecal IgA, faecal pH, and histological features of the intestinal mucosa of old dogs were evaluated. The same formulation was extruded in two different conditions: one to obtain elevated starch cooking degree with low RS content (0.21%) and the other lower starch cooking with high RS content (1.46%). Eight geriatric Beagles (11.5 ± 0.38 years old) were fed each diet for 61 days in a crossover design...
April 26, 2017: Journal of Animal Physiology and Animal Nutrition
https://www.readbyqxmd.com/read/28444605/recent-trends-of-modern-bacterial-insecticides-for-pest-control-practice-in-integrated-crop-management-system
#9
REVIEW
Pritam Chattopadhyay, Goutam Banerjee, Sayantan Mukherjee
Food security and safety are the major concern in ever expanding human population on the planet earth. Each and every year insect pests cause a serious damage in agricultural field that cost billions of dollars annually to farmers. The loss in term of productivity and high cost of chemical pesticides enhance the production cost. Irrespective use of chemical pesticides (such as Benzene hexachloride, Endosulfan, Aldicarb, and Fenobucarb) in agricultural field raised several types of environmental issues. Furthermore, continuous use of chemical pesticides creates a selective pressure which helps in emerging of resistance pest...
May 2017: 3 Biotech
https://www.readbyqxmd.com/read/28444600/antibiotic-sensitivity-pattern-of-indigenous-lactobacilli-isolated-from-curd-and-human-milk-samples
#10
Chetan Sharma, Sachin Gulati, Nishchal Thakur, Brij Pal Singh, Sanjolly Gupta, Simranpreet Kaur, Santosh Kumar Mishra, Anil Kumar Puniya, Jatinder Pal Singh Gill, Harsh Panwar
The gut microbiota plays a vital role in host well-being and lactic acid bacteria (LAB) have gained an overwhelming attention as health promoter. This perception has evolved from traditional dairy products to a money-spinning market of probiotics. The safety of probiotics is coupled to their intended use and LAB may act as pool of antimicrobial resistance genes that could be transferred to pathogens, either in food matrix or in gastrointestinal tract, which could be detrimental to host. This study evaluated the antibiotic susceptibility patterns of LAB isolated from curd (20) and human milk (11) samples...
May 2017: 3 Biotech
https://www.readbyqxmd.com/read/28444305/dissemination-of-gastroenteric-viruses-in-the-production-of-lettuce-in-developing-countries-a-public-health-concern
#11
Lucia M C Werneck, Carmen B Vieira, Tulio M Fumian, Thalles Borges Caetano, Jarbas Emílio Dos Santos, Fernando César Ferreira, Marcia Maria Pimenta, Marize P Miagostovich
Investigation of major viruses responsible for acute viral gastroenteritis, such as norovirus (NoV), rotavirus species A (RVA) and human adenovirus (HAdV), was conducted in the mountainous region of the state of Rio de Janeiro in a lettuce-producing area. Irrigation water and lettuce samples were collected at different production stages. Viruses were concentrated using an adsorption-elution method and detected by quantitative polymerase chain reaction (qPCR). We detected HAdV in all collection points, although no virus infectivity was shown...
April 21, 2017: FEMS Microbiology Letters
https://www.readbyqxmd.com/read/28444234/inferring-allele-frequency-trajectories-from-ancient-dna-indicates-that-selection-on-a-chicken-gene-coincided-with-changes-in-medieval-husbandry-practices
#12
Liisa Loog, Mark G Thomas, Ross Barnett, Richard Allen, Naomi Sykes, Ptolemaios D Paxinos, Ophelie Lebrasseur, Keith Dobney, Joris Peters, Andrea Manica, Greger Larson, Anders Eriksson
Ancient DNA provides an opportunity to infer the drivers of natural selection by linking allele frequency changes to temporal shifts in environment or cultural practices. However, analyses have often been hampered by uneven sampling and uncertainties in sample dating, as well as being confounded by demographic processes. Here we present a Bayesian statistical framework for quantifying the timing and strength of selection using ancient DNA that explicitly addresses these challenges. We applied this method to time series data for two loci: TSHR and BCDO2, both argued to have undergone strong and recent selection in domestic chickens...
April 21, 2017: Molecular Biology and Evolution
https://www.readbyqxmd.com/read/28444188/gas-chromatography-mass-spectrometry-method-to-quantify-benzo-a-pyrene-in-tobacco-products
#13
Karl A Wagner, Chorng B Huang, Matt S Melvin, Regina Ballentine, Naren K Meruva, Jason W Flora
The USA Food and Drug Administration (FDA) established benzo[a]pyrene (B[a]P) as a harmful and potentially harmful constituent (HPHC) found in tobacco products. Tobacco manufacturers are required to report HPHC quantities to the FDA; however, there is currently no standardized method for determination of B[a]P in smokeless tobacco products (STPs). This work details a sensitive, selective and rapid method for the determination of B[a]P in STPs, cigarette filler and tobacco. Tobacco is extracted using methanol followed by solid-phase extraction and concentration prior to analysis by gas chromatography/mass spectrometry in the selected ion monitoring mode...
April 21, 2017: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/28443536/effects-of-nesting-material-on-energy-homeostasis-in-balb-canncrl-c57bl-6ncrl-and-crl-cd1-icr-mice-housed-at-20-%C3%A2-c
#14
Daniel Taylor, Angela Green, Brianna Gaskill
Discrepancies exist between the preferred temperature range for mice (26 to 32 °C) and current recommendations (20 to26 °C), which may alter metabolism and negatively affect studies using mice. Previous research indicates that nesting materialcan alleviate cold stress in mice; therefore, we sought to determine the effects of the amount of nesting material provided(0, 6, or 12 g) on heat energy loss and energy balance in 3 mouse strains housed at currently recommended temperatures duringthe daytime, a period of presumed inactivity...
April 25, 2017: Journal of the American Association for Laboratory Animal Science: JAALAS
https://www.readbyqxmd.com/read/28443378/toxicity-resulting-from-exposure-to-oven-cleaners-as-reported-to-the-uk-national-poisons-information-service-npis-from-2009-to-2015
#15
Rachael C Day, Sally M Bradberry, Euan A Sandilands, Simon H L Thomas, John P Thompson, J Allister Vale
INTRODUCTION: Oven cleaning products contain corrosive substances, typically sodium or potassium hydroxide. OBJECTIVE: To determine the reported toxicity from exposure to oven cleaning products. METHODS: Telephone enquiries to the UK National Poisons Information Service regarding oven cleaning products were analysed retrospectively for the period January 2009 to December 2015. RESULTS: There were 796 enquiries relating to 780 patients...
April 26, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28443289/frequency-and-duration-of-fecal-shedding-of-salmonella-enteritidis-by-experimentally-infected-laying-hens-housed-in-enriched-colony-cages-at-different-stocking-densities
#16
Richard K Gast, Rupa Guraya, Deana R Jones, Kenneth E Anderson, Darrin M Karcher
Human infections with Salmonella Enteritidis are often attributed to the consumption of contaminated eggs, so the prevalence of this pathogen in egg-laying poultry is an important public health risk factor. Numerous and complex environmental influences on Salmonella persistence and transmission are exerted by management practices and housing facilities used in commercial egg production. In recent years, the animal welfare implications of poultry housing systems have guided the development of alternatives to traditional cage-based housing, but their food safety consequences are not yet fully understood...
2017: Frontiers in Veterinary Science
https://www.readbyqxmd.com/read/28443020/bgp-15-protects-against-oxaliplatin-induced-skeletal-myopathy-and-mitochondrial-reactive-oxygen-species-production-in-mice
#17
James C Sorensen, Aaron C Petersen, Cara A Timpani, Dean G Campelj, Jordan Cook, Adam J Trewin, Vanesa Stojanovska, Mathew Stewart, Alan Hayes, Emma Rybalka
Chemotherapy is a leading intervention against cancer. Albeit highly effective, chemotherapy has a multitude of deleterious side-effects including skeletal muscle wasting and fatigue, which considerably reduces patient quality of life and survivability. As such, a defense against chemotherapy-induced skeletal muscle dysfunction is required. Here we investigate the effects of oxaliplatin (OXA) treatment in mice on the skeletal muscle and mitochondria, and the capacity for the Poly ADP-ribose polymerase (PARP) inhibitor, BGP-15, to ameliorate any pathological side-effects induced by OXA...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28442935/new-developments-in-the-treatment-of-hypoactive-sexual-desire-disorder-a-focus-on-flibanserin
#18
REVIEW
Christopher J Jayne, Michael J Heard, Sarah Zubair, Dustie L Johnson
The objective of the authors is to highlight the historical complexities for the diagnosis and treatment of hypoactive sexual desire disorder (HSDD) with a focus on Flibanserin. A systematic review of the medical literature published in PubMed using the search terms HSDD and Flibanserin was conducted. Each author reviewed the results of the systematic review for articles to include in this study. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity causing marked distress or interpersonal difficulty that is not better accounted for by another diagnosis...
2017: International Journal of Women's Health
https://www.readbyqxmd.com/read/28442890/justification-of-disintegration-testing-beyond-current-fda-criteria-using-in-vitro-and-in-silico-models
#19
Lukas Uebbing, Lukas Klumpp, Gregory K Webster, Raimar Löbenberg
Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28442386/arginine-deiminase-pathway-provides-atp-and-boosts-growth-of-the-gas-fermenting-acetogen-clostridium-autoethanogenum
#20
Kaspar Valgepea, Kim Q Loi, James B Behrendorff, Renato de S P Lemgruber, Manuel Plan, Mark P Hodson, Michael Köpke, Lars K Nielsen, Esteban Marcellin
Acetogens are attractive organisms for the production of chemicals and fuels from inexpensive and non-food feedstocks such as syngas (CO, CO2 and H2). Expanding their product spectrum beyond native compounds is dictated by energetics, particularly ATP availability. Acetogens have evolved sophisticated strategies to conserve energy from reduction potential differences between major redox couples, however, this coupling is sensitive to small changes in thermodynamic equilibria. To accelerate the development of strains for energy-intensive products from gases, we used a genome-scale metabolic model (GEM) to explore alternative ATP-generating pathways in the gas-fermenting acetogen Clostridium autoethanogenum...
April 22, 2017: Metabolic Engineering
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