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https://www.readbyqxmd.com/read/29143657/clinical-benefits-of-incorporating-doxycycline-into-a-canine-heartworm-treatment-protocol
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/29057550/in-vitro-magnetic-resonance-imaging-evaluation-of-fragmented-open-coil-percutaneous-peripheral-nerve-stimulation-leads
#10
Frank G Shellock, Armaan Zare, Brian M Ilfeld, John Chae, Robert B Strother
OBJECTIVE: Percutaneous peripheral nerve stimulation (PNS) is an FDA-cleared pain treatment. Occasionally, fragments of the lead (MicroLead, SPR Therapeutics, LLC, Cleveland, OH, USA) may be retained following lead removal. Since the lead is metallic, there are associated magnetic resonance imaging (MRI) risks. Therefore, the objective of this investigation was to evaluate MRI-related issues (i.e., magnetic field interactions, heating, and artifacts) for various lead fragments. METHODS: Testing was conducted using standardized techniques on lead fragments of different lengths (i...
October 23, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/29048252/stigma-communication-surrounding-prep-the-experiences-of-a-sample-of-men-who-have-sex-with-men
#11
Joseph Schwartz, Josh Grimm
HIV is a serious problem in the USA, particularly for men who have sex with men (MSM). A new means of HIV prevention, called pre-exposure prophylaxis (PrEP), has been shown to be highly effective. However, in spite of earning FDA approval, adoption of PrEP by MSM has been limited. The purpose of this study was to examine the experiences of a sample of 38 MSM who have adopted PrEP, focusing on communication with healthcare providers and social networks. In-depth interviews were used to collect data. Findings revealed that stigmatization by healthcare providers as well as stigmatization by other MSM was a relatively common experience for participants...
October 19, 2017: Health Communication
https://www.readbyqxmd.com/read/29019750/contrast-enhanced-us-assessment-of-focal-liver-lesions-in-children
#12
Sudha A Anupindi, David M Biko, Aikaterini Ntoulia, Laura Poznick, Trudy A Morgan, Kassa Darge, Susan J Back
Ultrasonography (US) is often the first line of imaging for the examination of children suspected of having liver lesions. However, gray-scale US with color Doppler imaging has limitations. The use of US contrast agents has recently been approved by the U.S. Food and Drug Administration (FDA). Compared with other imaging modalities, contrast material-enhanced US (CEUS) enables the assessment of contrast enhancement patterns with a higher temporal resolution and is therefore becoming a valuable alternative imaging technique...
October 2017: Radiographics: a Review Publication of the Radiological Society of North America, Inc
https://www.readbyqxmd.com/read/29019016/repurposing-zidovudine-in-combination-with-tigecycline-for-treating-carbapenem-resistant-enterobacteriaceae-infections
#13
S M S Ng, J S P Sioson, J M Yap, F M Ng, H S V Ching, J W P Teo, R Jureen, J Hill, C S B Chia
The global emergence of carbapenem-resistant Enterobacteriaceae (CRE) presents a significant clinical concern, prompting the WHO to prioritize CRE as a top priority pathogen in their 2017 global antibiotic-resistant bacteria priority list. Due to the fast-depleting antibiotic arsenal, clinicians are now resorting to using once-abandoned, highly toxic antibiotics such as the polymyxins and aminoglycosides, creating an urgent need for new antibiotics. Drug repurposing, the application of an approved drug for a new therapeutic indication, is deemed a plausible solution to this problem...
October 10, 2017: European Journal of Clinical Microbiology & Infectious Diseases
https://www.readbyqxmd.com/read/28988570/alcoholic-liver-disease-pathogenesis-and-current-management
#14
Natalia A Osna, Terrence M Donohue, Kusum K Kharbanda
Excessive alcohol consumption is a global healthcare problem. The liver sustains the greatest degree of tissue injury by heavy drinking because it is the primary site of ethanol metabolism. Chronic and excessive alcohol consumption produces a wide spectrum of hepatic lesions, the most characteristic of which are steatosis, hepatitis, and fibrosis/cirrhosis. Steatosis is the earliest response to heavy drinking and is characterized by the deposition of fat in hepatocytes. Steatosis can progress to steatohepatitis, which is a more severe, inflammatory type of liver injury...
2017: Alcohol Research: Current Reviews
https://www.readbyqxmd.com/read/28966636/heterocyclic-compounds-as-key-structures-for-the-interaction-with-old-and-new-targets-in-alzheimer-s-disease-therapy
#15
REVIEW
Asha Hiremathad, Luca Piemontese
Nowadays, Alzheimer's disease (AD) is widely recognized as a real social problem. In fact, only five drugs are FDA approved for the therapy of this widespread neurodegenerative disease, but with low results so far. Three of them (rivastigmine, donepezil and galantamine) are acetylcholinesterase inhibitors, memantine is a N-methyl-D-aspartate receptor antagonist, whereas the fifth formulation is a combination of donepezil with memantine. The prevention and treatment of AD is the new challenge for pharmaceutical industry, as well as for public institutions, physicians, patients, and their families...
August 2017: Neural Regeneration Research
https://www.readbyqxmd.com/read/28956294/the-impact-of-us-fda-and-health-canada-warnings-related-to-the-safety-of-high-dose-simvastatin
#16
Kanika Anand, Ingrid Sketris, Ying Zhang, Adrian Levy, John-Michael Gamble
INTRODUCTION: Between 2010 and 2012, the US Food and Drug Administration and Health Canada issued warnings to healthcare professionals emphasizing the increased risk of muscle problems with high-dose simvastatin. OBJECTIVE: To measure the impact of the Health Canada safety warning regarding dose-dependent adverse effects of simvastatin on prescribing of low, medium, and high doses of simvastatin. METHODS: An interrupted time-series design was used to evaluate the impact of a Health Canada safety warning on 7 November 2012 regarding the safety of high-dose simvastatin...
December 2017: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/28946891/development-of-the-pediatric-daily-ulcerative-colitis-signs-and-symptoms-scale-ducs-qualitative-research-findings
#17
Emuella Flood, Debra G Silberg, Beverly Romero, Kathleen Beusterien, M Haim Erder, Carmen Cuffari
BACKGROUND: The purpose of this study is to develop patient-reported (PRO) and observer-reported (ObsRO) outcome measures of ulcerative colitis (UC) signs/symptoms in children aged 5-17 with mild/moderate UC. The daily ulcerative colitis signs and symptoms scale (DUCS) was developed in two phases. Phase I involved concept elicitation interviews with patients and healthcare providers, review of website posts and item generation. Phase II involved cognitive debriefing and assessment of usability and feasibility of the eDiaries...
September 25, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28944741/the-application-of-nanoparticles-for-neuroprotection-in-acute-ischemic-stroke
#18
Lepei Chen, Xiaoling Gao
Stroke still represents one of the most common causes of death and disability worldwide. Acute ischemic stroke (AIS), caused by brain arterial occlusion resulting from a thrombus or embolus, is the most common form of stroke. However, current therapies in AIS are inadequate, and the only US FDA approved treatment is the thrombolytic drug Alteplase. Therefore, establishing effective therapeutic strategies for AIS is urgently needed. Using nanoparticle-based technologies to deliver neuroprotective agents to the ischemic area has attracted increasing attention of late...
October 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28935287/past-present-and-future-of-pharmacotherapy-for-obesity
#19
David Benaiges, Juan Pedro-Botet, Juana A Flores-Le Roux, Elisenda Climent, Albert Goday
Conventional treatment for obesity with diet, exercise and bariatric surgery has limitations; thus, it is necessary to have pharmacological tools. In the past, different drugs were marketed that were withdrawn due to safety problems. There are currently 3 drugs approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for obesity therapy (orlistat, combination of bupropion and delayed-release naltrexone and liraglutide) and two more only authorized by FDA (lorcaserin and the combination of phentermine and extended release topiramate)...
September 18, 2017: Clínica e Investigación en Arteriosclerosis
https://www.readbyqxmd.com/read/28931213/a-review-on-the-efficacy-and-toxicity-of-different-doxorubicin-nanoparticles-for-targeted-therapy-in-metastatic-breast-cancer
#20
REVIEW
Ayman Shafei, Wesam El-Bakly, Ahmed Sobhy, Omar Wagdy, Ahmed Reda, Omar Aboelenin, Amr Marzouk, Khalil El Habak, Randa Mostafa, Mahmoud A Ali, Mahmoud Ellithy
In metastatic breast cancer (MBC), the conventional doxorubicin (DOX) has various problems due to lack of selectivity with subsequent therapeutic failure and adverse effects. DOX- induced cardiotoxicity is a major problem that necessitates the presence of new forms to decrease the risk of associated morbidity. Nanoparticles (NPs) are considered an important approach to selectively increase drug accumulation inside tumor cells and thus decreasing the associated side effects. Tumor cells develop resistance to chemotherapeutic agents through multiple mechanisms, one of which is over expression of efflux transporters...
November 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
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