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https://www.readbyqxmd.com/read/29350758/obesity-and-pediatric-drug-development
#1
Janelle D Vaughns, Laurie S Conklin, Ying Long, Panli Zheng, Fahim Faruque, Dionna J Green, John N van den Anker, Gilbert J Burckart
There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies...
January 19, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29339248/recent-trends-of-nanomedicinal-approaches-in-clinics
#2
REVIEW
Fahima Dilnawaz, Sarbari Acharya, Sanjeeb Kumar Sahoo
Nanotechnology has become the indispensable cutting edge science providing solutions to many problems associated with human being. The application of nanotechnology associated to human health "nanomedicine" has revolutionized the drug delivery system by providing improved pharmacological and therapeutic properties of drugs. These advantageous effects of drug loaded nanocarrier systems are embraced by the pharmaceutical industries for the development of different effective nanocarriers. Currently, several drug loaded nanoformulations are approved by the Food and Drug Administration (FDA), and some of them are undergoing clinical trials for the human use...
January 12, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29317163/investigations-into-the-efficacy-of-multi-component-cocaine-vaccines
#3
Atsushi Kimishima, Margaret E Olson, Kim D Janda
Although cocaine addiction remains a serious health and societal problem in the United States, no FDA-approved treatment has been developed. Vaccines offer an exciting strategy for the treatment of cocaine addiction; however, vaccine formulations need to be optimized to improve efficacy. Herein, we examine the effectiveness of a tricomponent cocaine vaccine, defined as having its hapten (GNE) and adjuvant (cytosine-guanine oligodeoxynucleotide 1826, CpG ODN 1826) covalently linked via the immunogenic protein ovalbumin (OVA)...
December 20, 2017: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/29274915/differences-in-fecal-microbial-metabolites-and-microbiota-of-children-with-autism-spectrum-disorders
#4
Dae-Wook Kang, Zehra Esra Ilhan, Nancy G Isern, David W Hoyt, Daniel P Howsmon, Michael Shaffer, Catherine A Lozupone, Juergen Hahn, James B Adams, Rosa Krajmalnik-Brown
Evidence supporting that gut problems are linked to ASD symptoms has been accumulating both in humans and animal models of ASD. Gut microbes and their metabolites may be linked not only to GI problems but also to ASD behavior symptoms. Despite this high interest, most previous studies have looked mainly at microbial structure, and studies on fecal metabolites are rare in the context of ASD. Thus, we aimed to detect fecal metabolites that may be present at significantly different concentrations between 21 children with ASD and 23 neurotypical children and to investigate its possible link to human gut microbiome...
December 21, 2017: Anaerobe
https://www.readbyqxmd.com/read/29273821/the-abuse-potential-of-kratom-according-the-8-factors-of-the-controlled-substances-act-implications-for-regulation-and-research
#5
REVIEW
Jack E Henningfield, Reginald V Fant, Daniel W Wang
RATIONALE: Consideration by the US Drug Enforcement Administration and Food and Drug Administration of placing kratom into Schedule I of the Controlled Substances Act (CSA) requires its evaluation of abuse potential in the context of public health. OBJECTIVE: The objective of the study is to provide a review of kratom abuse potential and its evaluation according to the 8 factors of the CSA. RESULTS: Kratom leaves and extracts have been used for centuries in Southeast Asia and elsewhere to manage pain and other disorders and, by mid-twentieth century, to manage opioid withdrawal...
December 23, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/29261673/we-are-what-we-eat-regulatory-gaps-in-the-united-states-that-put-our-health-at-risk
#6
Maricel V Maffini, Thomas G Neltner, Sarah Vogel
The American diet has changed dramatically since 1958, when Congress gave the United States Food and Drug Administration (FDA) the authority to ensure the safety of chemicals in food. Since then, thousands of chemicals have entered the food system. Yet their long-term, chronic effects have been woefully understudied, their health risks inadequately assessed. The FDA has been sluggish in considering scientific knowledge about the impact of exposures-particularly at low levels and during susceptible developmental stages...
December 2017: PLoS Biology
https://www.readbyqxmd.com/read/29234546/repigmentation-of-tenacious-vitiligo-on-apremilast
#7
Sara B Huff, Lorie D Gottwald
Vitiligo is a common pigment disorder characterized by acquired loss of function or absence of melanocytes, leading to distinct areas of depigmentation. Physical exam reveals sharply demarcated, depigmented macules or patches on otherwise normal skin. Vitiligo can present at any age, in any skin color. There is no specific serologic marker for diagnosis, but patients often have other autoimmune problems. Treatment options are limited and are difficult given the fact that the pathogenesis of the disease is not well elucidated...
2017: Case Reports in Dermatological Medicine
https://www.readbyqxmd.com/read/29229851/structure-based-prediction-of-ligand-protein-interactions-on-a-genome-wide-scale
#8
Howook Hwang, Fabian Dey, Donald Petrey, Barry Honig
We report a template-based method, LT-scanner, which scans the human proteome using protein structural alignment to identify proteins that are likely to bind ligands that are present in experimentally determined complexes. A scoring function that rapidly accounts for binding site similarities between the template and the proteins being scanned is a crucial feature of the method. The overall approach is first tested based on its ability to predict the residues on the surface of a protein that are likely to bind small-molecule ligands...
December 11, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29189709/non-canonical-thinking-for-targeting-alk-fusion-onco-proteins-in-lung-cancer
#9
REVIEW
Wei Wu, Franziska Haderk, Trever G Bivona
Anaplastic lymphoma kinase (ALK) gene rearrangements have been identified in lung cancer at 3-7% frequency, thus representing an important subset of genetic lesions that drive oncogenesis in this disease. Despite the availability of multiple FDA-approved small molecule inhibitors targeting ALK fusion proteins, drug resistance to ALK kinase inhibitors is a common problem in clinic. Thus, there is an unmet need to deepen the current understanding of genomic characteristics of ALK rearrangements and to develop novel therapeutic strategies that can overcome ALK inhibitor resistance...
November 30, 2017: Cancers
https://www.readbyqxmd.com/read/29187031/minocycline-plus-n-acetylcysteine-reduce-behavioral-deficits-and-improve-histology-with-a-clinically-useful-time-window
#10
Michael Sangobowale, Natalia M Grin'kina, Kristen Whitney, Elena Nikulina, Karrah St Laurent-Arriot, Johnson S Ho, Narek Bazyan, Peter Bergold
There are presently no drugs to treat traumatic brain injury (TBI). A major problem in developing therapeutics is that drugs to treat TBI lack sufficient potency when dosed within a clinically relevant time window. Previous studies have shown that minocycline (MINO, 45mg/kg) plus N-acetylcysteine (NAC, 150mg/kg) synergistically improved cognition and memory, modulated inflammation and prevented loss of oligodendrocytes that remyelinated damaged white matter when first dosed 1 hour (h) after controlled cortical impact (CCI) in rats...
November 29, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/29182464/triclosan-exposure-transformation-and-human-health-effects
#11
REVIEW
Lisa M Weatherly, Julie A Gosse
Triclosan (TCS) is an antimicrobial used so ubiquitously that 75% of the US population is likely exposed to this compound via consumer goods and personal care products. In September 2016, TCS was banned from soap products following the risk assessment by the US Food and Drug Administration (FDA). However, TCS still remains, at high concentrations, in other personal care products such as toothpaste, mouthwash, hand sanitizer, and surgical soaps. TCS is readily absorbed into human skin and oral mucosa and found in various human tissues and fluids...
2017: Journal of Toxicology and Environmental Health. Part B, Critical Reviews
https://www.readbyqxmd.com/read/29143657/clinical-benefits-of-incorporating-doxycycline-into-a-canine-heartworm-treatment-protocol
#12
C Thomas Nelson, Elizabeth S Myrick, Thomas A Nelson
BACKGROUND: The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA), in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated...
November 9, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/29140657/sunlight-and-other-disinfectants-disclosure-obligations-under-the-federal-securities-and-drug-regulatory-regimes
#13
Joseph G Milner
Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29140656/an-analysis-of-%C3%A2-natural%C3%A2-food-litigation-to-build-a-sesame-allergy-consumer-class-action
#14
Dana Shaker
In a world where food allergy is still an incurable disease, law and regulation stand as necessary mechanisms to provide food-allergic consumers with the information they need to protect their health. The Food Allergen Labeling and Consumer Protection Act of 2004 provided specific labeling requirements for the “Top Eight” allergens in the U.S.: milk, soy, gluten, egg, tree nut, peanut, fish, and Crustacean shellfish. Since then, sesame has become more prevalent as an allergen and remains just as dangerous, inducing anaphylactic shock in some sesame-allergic individuals...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29140653/outsource-power-import-safety-challenges-and-opportunities-of-the-u-s-china-food-safety-regulatory-cooperation
#15
Ching-Fu Lin
The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29140651/fda-required-tobacco-product-inserts-onserts%C3%A2-and-the-first-amendment
#16
Eric N Lindblom, Micah L Berman, James F Thrasher
In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29101575/current-and-future-treatments-for-lysosomal-storage-disorders
#17
REVIEW
David P W Rastall, Andrea Amalfitano
Purpose of review Lysosomal storage disorders (LSDs) are a class of genetic disorders that are a testing ground for the invention of novel therapeutics including enzyme replacement therapy (ERT), substrate reduction therapy (SRT), gene therapy, and hematopoietic stem cell transplant (HSCT). This review summarizes recently approved drugs, then examines the successful clinical trials in gene therapy and HSCT. Recent findings The FDA has recently approved a second SRT by reversing an earlier FDA decision, suggesting a favorable regulatory landscape going forward...
November 4, 2017: Current Treatment Options in Neurology
https://www.readbyqxmd.com/read/29094174/contrast-enhanced-ultrasound-of-malignant-liver-lesions
#18
Isabelle Durot, Stephanie R Wilson, Jürgen K Willmann
Contrast-enhanced ultrasound (CEUS) is a safe, relatively inexpensive, and widely available imaging technique using dedicated imaging ultrasound sequences and FDA-approved contrast microbubbles that allow detection and characterization of malignant focal liver lesions with high diagnostic accuracy. CEUS provides dynamic real-time imaging with high spatial and temporal capability, allowing for unique contributions to the already established protocols for diagnosing focal liver lesions using CT and MR imaging...
November 1, 2017: Abdominal Radiology
https://www.readbyqxmd.com/read/29090536/-consideration-about-chemistry-manufacture-and-control-cmc-key-problems-in-simplified-registration-of-classical-traditional-chinese-medicine-excellent-prescriptions
#19
Zhi-Min Wang, Ju-Yan Liu, Xiao-Qian Liu, De-Qin Wang, Li-Hua Yan, Jin-Jin Zhu, Hui-Min Gao, Chun Li, Jin-Yu Wang, Chu-Yuan Li, Qing-Chun Ni, Ji-Sheng Huang, Juan Lin
As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties, classical TCM excellent prescriptions (cTCMeP) are the most valuable part of TCM system. To support the research and development of cTCMeP, a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology, registration and administration in cTCMeP R&D process are not resolved...
May 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29058787/drug-repurposing-an-approach-to-tackle-drug-resistance-in-s-typhimurium
#20
B Preethi, V Shanthi, K Suthindhiran, K Ramanathan
Drug resistant S. typhimurium pose important public health problem. The development of effective drugs with novel mechanism(s) of action is needed to overcome issues pertaining to drug resistance. Drug repurposing based on computational analyses is considered a viable alternative strategy to circumvent this issue. In this context, 1309 FDA-approved drugs molecules from Mantra 2.0 database were analysed for this study, against S. typhimurium. Sixteen compounds having similar profiles of gene expression as quinolones were identified from the database, Mantra 2...
October 23, 2017: Journal of Cellular Biochemistry
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