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https://www.readbyqxmd.com/read/28748626/combining-bottom-up-and-top-down-approaches-to-assess-the-impact-of-food-and-gastric-ph-on-pictilisib-gdc-0941-pharmacokinetics
#1
Tong Lu, Grazyna Fraczkiewicz, Laurent Salphati, Nageshwar Budha, Gena Dalziel, Gillian S Smelick, Kari M Morrissey, John D Davis, Jin Y Jin, Joseph A Ware
Pictilisib, a weakly basic compound, is an orally administered, potent, and selective pan-inhibitor of phosphatidylinositol 3-kinases for oncology indications. To investigate the significance of high-fat food and gastric pH on pictilisib pharmacokinetics (PK) and enable label recommendations, a dedicated clinical study was conducted in healthy volunteers, whereby both top-down [Population PK, (PopPK)] and bottom-up [physiologically-based PK, (PBPK)] approaches were applied to enhance confidence of recommendation and facilitate the clinical development through scenario simulations...
July 27, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28748132/effects-of-intake-of-lactobacillus-casei-subsp-casei-327-on-skin-conditions-a-randomized-double-blind-placebo-controlled-parallel-group-study-in-women
#2
Yuhi Saito, Toshihiro Mihara, Kentaro Maruyama, Jiro Saito, Masumi Ikeda, Akihito Tomonaga, Takehisa Kumagai
Lactic acid bacteria are gut flora that play key roles in intestinal homeostasis, which may affect a variety of physiological functions. Our preliminary double-blind, placebo-controlled, parallel-group trials have suggested that intake of heat-killed Lactobacillus casei subsp. casei 327 (designated L. K-1) is effective for improving skin conditions. The aim of this study was to confirm the effect of L. K-1 intake in a randomized, double-blind, placebo-controlled, parallel-group study in healthy female volunteers...
2017: Bioscience of Microbiota, Food and Health
https://www.readbyqxmd.com/read/28748076/allergens-labeling-on-french-processed-foods-an-oqali-study
#3
Charlène Battisti, Amélie Chambefort, Olivier Digaud, Barbara Duplessis, Cécile Perrin, Jean-Luc Volatier, Julie Gauvreau-Béziat, Céline Menard
The French Observatory of Food Quality (Oqali) aims at collecting all nutritional data provided on labels of processed foods (nutritional information and composition), at branded products level, in order to follow nutritional labeling changes over time. This study carries out an overview of allergens labeling frequencies by distinguishing allergens used in recipes from those listed on precautionary statements, for the fourteen allergen categories for which labeling is mandatory according to European legislation...
July 2017: Food Science & Nutrition
https://www.readbyqxmd.com/read/28747833/identification-of-pork-adulteration-in-processed-meat-products-using-the-developed-mitochondrial-dna-based-primers
#4
Jimyeong Ha, Sejeong Kim, Jeeyeon Lee, Soomin Lee, Heeyoung Lee, Yukyung Choi, Hyemin Oh, Yohan Yoon
The identification of pork in commercially processed meats is one of the most crucial issues in the food industry because of religious food ethics, medical purposes, and intentional adulteration to decrease production cost. This study therefore aimed to develop a method for the detection of pork adulteration in meat products using primers specific for pig mitochondrial DNA. Mitochondrial DNA sequences for pig, cattle, chicken, and sheep were obtained from GenBank and aligned. The 294-bp mitochondrial DNA D-loop region was selected as the pig target DNA sequence and appropriate primers were designed using the MUSCLE program...
2017: Korean Journal for Food Science of Animal Resources
https://www.readbyqxmd.com/read/28744102/bioequivalence-of-generic-alendronate-sodium-tablets-70-mg-to-fosamax-%C3%A2-tablets-70-mg-in-fasting-healthy-volunteers-a-randomized-open-label-three-way-reference-replicated-crossover-study
#5
Yifan Zhang, Xiaoyan Chen, Yunbiao Tang, Youming Lu, Lixia Guo, Dafang Zhong
PURPOSE: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax(®) 70 mg tablet. MATERIALS AND METHODS: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg)...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28741904/prevention-of-childhood-obesity-and-food-policies-in-latin-america-from-research-to-practice
#6
R Pérez-Escamilla, C K Lutter, C Rabadan-Diehl, A Rubinstein, A Calvillo, C Corvalán, C Batis, E Jacoby, S Vorkoper, L Kline, E Ewart-Pierce, J A Rivera
BACKGROUND: Addressing childhood obesity in Latin America requires a package of multisectoral, evidence-based policies that enable environments conducive to healthy lifestyles. OBJECTIVE: Identify and examine key elements to translating research into effective obesity policies in Latin America. METHODS: We examined obesity prevention policies through case studies developed with an expert in the specific policy. Policies were selected based on their level of implementation, visibility and potential impact to reduce childhood obesity...
July 2017: Obesity Reviews: An Official Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/28740906/the-development-commercialization-and-clinical-context-of-yttrium-90-radiolabeled-resin-and-glass-microspheres
#7
REVIEW
Mark A Westcott, Douglas M Coldwell, David M Liu, Joseph F Zikria
Selective internal radiation therapy has emerged as a well-accepted therapeutic for primary and metastatic hepatic malignancies. This therapeutic modality requires the combined efforts of multiple medical disciplines to ensure the safe delivery of yttrium-90 ((90)Y)-labeled microspheres. The development of this therapy followed decades of clinical research involving tumor vascularity and microsphere development. Today, it is essential that treating physicians have a thorough understanding of hepatic tumor vascularity and (90)Y microsphere characteristics before undertaking this complex intervention...
October 2016: Advances in Radiation Oncology
https://www.readbyqxmd.com/read/28739655/critical-issues-in-food-allergy-a-national-academies-consensus-report
#8
Scott H Sicherer, Katrina Allen, Gideon Lack, Steve L Taylor, Sharon M Donovan, Maria Oria
The National Academies of Sciences, Engineering, and Medicine convened an expert, ad hoc committee to examine critical issues related to food allergy. The authors of the resulting report, "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy," evaluated the scientific evidence on the prevalence, diagnosis, prevention, and management of food allergy and made recommendations to bring about a safe environment for those affected. The committee recommended approaches to monitor prevalence, explore risk factors, improve diagnosis, and provide evidence-based health care...
July 24, 2017: Pediatrics
https://www.readbyqxmd.com/read/28737692/salt-reductions-in-some-foods-in-the-netherlands-monitoring-of-food-composition-and-salt-intake
#9
Elisabeth H M Temme, Marieke A H Hendriksen, Ivon E J Milder, Ido B Toxopeus, Susanne Westenbrink, Henny A M Brants, Daphne L van der A
BACKGROUND AND OBJECTIVES: High salt intake increases blood pressure and thereby the risk of chronic diseases. Food reformulation (or food product improvement) may lower the dietary intake of salt. This study describes the changes in salt contents of foods in the Dutch market over a five-year period (2011-2016) and differences in estimated salt intake over a 10-year period (2006-2015). METHODS: To assess the salt contents of foods; we obtained recent data from chemical analyses and from food labels...
July 22, 2017: Nutrients
https://www.readbyqxmd.com/read/28737128/bioequivalence-of-two-oseltamivir-formulations-in-healthy-chinese-volunteers%C3%A2
#10
Yun-Lei Yun, Shou-Hong Gao, Yan Wen, Zhi-Peng Wang, Hai-Jun Miao, Wan-Sheng Chen
BACKGROUND: The aim of this study was to compare the bioavailability of a new generic formulation of oseltamivir 75-mg capsule (test) and a branded formulation Tamiflu® (reference) to meet regulatory criteria for marketing the test product in healthy Chinese male volunteers. METHODS: This single-dose, randomized-sequence, open-label, two-period crossover study was conducted in fasted healthy Chinese male volunteers, who first received a single oral dose of the test or reference formulation with a 7-day washout period, and then the alternative formulation...
July 24, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28734860/the-expanding-field-of-biologics-in-the-management-of-chronic-urticaria
#11
Shyam Joshi, David A Khan
Chronic urticaria (CU) is the occurrence of urticaria with or without angioedema for at least 6 weeks. Management has traditionally involved antihistamines as first-line therapy with various alternative therapies for refractory cases. Largely based on the success of biologics for various diseases, this class of drugs has come to the forefront of medical research. The first and only Food and Drug Administration-approved biologic for the management of CU is omalizumab (humanized anti-IgE mAb). In the past decade, a substantial amount of research has been centered on the mechanism of action, efficacy, dosing, and safety of omalizumab...
July 19, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28733711/a-brief-history-of-neurological-botulinum-toxin-therapy-in-germany
#12
REVIEW
Dirk Dressler, Peter Roggenkaemper
Botulinum toxin (BT) has long been infamous in food safety and biological warfare. In the early 1970s, Alan B Scott of San Francisco invented its therapeutic use originally in extraocular eye muscles to treat strabismus using a therapeutic BT type A preparation provided by Edward J Schantz and Eric A Johnson. Subsequently a large number of medical indications based on motor and glandular hyperactivity and-most recently-chronic migraine are now treated by BT therapy. BT's highly specific and elaborate mechanism of action represents a completely novel therapeutic principle which will have consequences far beyond existing indications...
July 21, 2017: Journal of Neural Transmission
https://www.readbyqxmd.com/read/28729812/what-are-interesterified-fats-and-should-we-be-worried-about-them-in-our-diet
#13
C E Mills, W L Hall, S E E Berry
Interesterified (IE) fats are used in a wide range of food products and were introduced as a replacement for trans fats, which are known to be detrimental to cardiovascular health. However, the effects of interesterification on metabolism and subsequent effects on cardiovascular health are not understood and previous studies have seldom investigated industrially-relevant IE fats. No legislation currently exists regarding the labelling of IE fats in food products and therefore estimates of average consumption rates in the UK population are currently unavailable...
June 2017: Nutrition Bulletin
https://www.readbyqxmd.com/read/28729021/ascend-8-a-randomized-phase-1-study-of-ceritinib-450-mg-or-600-mg-taken-with-a-low-fat-meal-versus-750-mg-in-fasted-state-in-patients-with-anaplastic-lymphoma-kinase-alk-rearranged-metastatic-non-small-cell-lung-cancer-nsclc
#14
Byoung Chul Cho, Dong-Wan Kim, Alessandra Bearz, Scott A Laurie, Mark McKeage, Gloria Borra, Keunchil Park, Sang-We Kim, Marwan Ghosn, Andrea Ardizzoni, Evaristo Maiello, Alastair Greystoke, Richard Yu, Karen Osborne, Wen Gu, Jeffrey W Scott, Vanessa Q Passos, Yvonne Y Lau, Anna Wrona
INTRODUCTION: Ceritinib 750 mg fasted is approved for treatment of anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC) patients previously treated with crizotinib. Part 1 of ASCEND-8 study determined whether administering ceritinib 450 mg or 600 mg with a low-fat meal may enhance gastrointestinal (GI) tolerability vs 750 mg fasted in ALK+ NSCLC patients while maintaining similar exposure. METHODS: ASCEND-8 is a multicenter, randomized, open-label, phase 1 study...
July 17, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28728058/high-prevalence-of-esbls-in-retail-chicken-meat-despite-reduced-use-of-antimicrobials-in-chicken-production-france
#15
Tiago Casella, Mara Correa Lelles Nogueira, Estelle Saras, Marisa Haenni, Jean-Yves Madec
Extended-spectrum cephalosporins (ESCs) are critically important antibiotics for humans and their use in animals poses a potential threat for public health. Chicken represents an increasing part of the human diet and has also been regarded as a source of ESC-resistant Enterobacteriaceae because of the worldwide off-label use of ceftiofur, a broad-spectrum cephalosporin. Thus, numerous studies pointed out chicken as a reservoir of ESBL/pAmpC genes, plasmids and/or clones at risk for humans. In France, late 2011, strong political pressure led to a drastic reduction of ceftiofur use and all other antibiotics in chicken production...
July 10, 2017: International Journal of Food Microbiology
https://www.readbyqxmd.com/read/28727958/lipid-injectable-emulsion-survey-with-gap-analysis
#16
Michael L Christensen, Phil Ayers, Joseph I Boullata, Peggi Guenter, Kathleen M Gura, Beverly Holcombe, David S Seres, Gordon S Sacks
BACKGROUND: Lipid injectable emulsion (ILE) is an integral part of parenteral nutrition (PN), providing energy and essential fatty acids. With recent consensus recommendations for PN, clinical guidelines for ordering and preparation of PN, the U.S. Food and Drug Administration approval of new ILE products, and revised ILE labeling to include a 1.2-micron filter, a gap in current practice knowledge was apparent. MATERIALS AND METHODS: The American Society for Parenteral and Enteral Nutrition PN Safety Committee surveyed clinicians on how ILE products are prescribed, prepared, and administered to patients from neonates to adults...
July 1, 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28727079/detection-of-dietary-dna-protein-and-glyphosate-in-meat-milk-and-eggs
#17
A L Van Eenennaam, A E Young
Products such as meat, milk, and eggs from animals that have consumed genetically engineered (GE) feed are not currently subject to mandatory GE labeling requirements. Some voluntary "non-genetically modified organism" labeling has been associated with such products, indicating that the animals were not fed GE crops, as there are no commercialized GE food animals. This review summarizes the available scientific literature on the detection of dietary DNA and protein in animal products and briefly discusses the implications of mandatory GE labeling for products from animals that have consumed GE feed...
July 2017: Journal of Animal Science
https://www.readbyqxmd.com/read/28724452/exercise-energy-expenditure-and-energy-balance-as-measured-with-doubly-labelled-water
#18
Klaas R Westerterp
The doubly labelled water method for the measurement of total daily energy expenditure (TDEE) over 1-3 weeks under daily living conditions is the indicated method to study effects of exercise and extreme environments on energy balance. Subjects consume a measured amount of doubly labelled water (2H2 18O) to increase background enrichment of body water for 18O and 2H, and the subsequent difference in elimination rate between 18O and 2H, as measured in urine, saliva or blood samples, is a measure for carbon dioxide production and thus allows calculation of TDEE...
July 20, 2017: Proceedings of the Nutrition Society
https://www.readbyqxmd.com/read/28723333/enhanced-prophylaxis-plus-antiretroviral-therapy-for-advanced-hiv-infection-in-africa
#19
James Hakim, Victor Musiime, Alex J Szubert, Jane Mallewa, Abraham Siika, Clara Agutu, Simon Walker, Sarah L Pett, Mutsa Bwakura-Dangarembizi, Abbas Lugemwa, Symon Kaunda, Mercy Karoney, Godfrey Musoro, Sheila Kabahenda, Kusum Nathoo, Kathryn Maitland, Anna Griffiths, Margaret J Thomason, Cissy Kityo, Peter Mugyenyi, Andrew J Prendergast, A Sarah Walker, Diana M Gibb
BACKGROUND: In sub-Saharan Africa, among patients with advanced human immunodeficiency virus (HIV) infection, the rate of death from infection (including tuberculosis and cryptococcus) shortly after the initiation of antiretroviral therapy (ART) is approximately 10%. METHODS: In this factorial open-label trial conducted in Uganda, Zimbabwe, Malawi, and Kenya, we enrolled HIV-infected adults and children 5 years of age or older who had not received previous ART and were starting ART with a CD4+ count of fewer than 100 cells per cubic millimeter...
July 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28723196/label-free-homogeneous-electroanalytical-platform-for-pesticide-detection-based-on-acetylcholinesterase-mediated-dna-conformational-switch-integrated-with-rolling-circle-amplification
#20
Xiaojuan Liu, Mengmeng Song, Ting Hou, Feng Li
This study addresses the need for sensitive pesticide assay by reporting a new label-free and immobilization-free homogeneous electroanalytical strategy, which combines acetylcholinesterase (AChE)-catalyzed hydrolysis product-mediated DNA conformational switch and rolling circle amplification (RCA) to detect organophosphorous and carbamate pesticides in a "signal-on" mode. When target pesticides were present, AChE activity was inhibited and could not trigger the following DNA conformational change and the RCA reaction, which results in numerous methylene blue (MB) molecules in a free state, generating a strong electrochemical response...
April 28, 2017: ACS Sensors
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