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https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#1
J Braun, J Kay
Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest...
January 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28068518/impact-of-space-environment-on-stability-of-medicines-challenges-and-prospects
#2
REVIEW
Priti Mehta, Dhara Bhayani
To upkeep health of astronauts in a unique, isolated, and extreme environment of space is the primary goal for a successful space mission, hence, safe and efficacious medications are essential for the wellness of astronauts. Space medication has been challenged with problems related to efficacy. Along with altered physiology, one of the possible reasons could be instability of space medications in the presence of harsh spaceflight environmental conditions. Altered physical and chemical stability can result in reduced potency which can result in reduced efficacy...
January 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28066115/comparison-of-the-knowledge-attitude-and-practices-of-doctors-nurses-and-pharmacists-regarding-the-use-of-expired-and-disposal-of-unused-medicines-in-delhi
#3
Kriti Bhayana, Harmeet Singh Rehan, Tarun Arora
OBJECTIVES: The use of out-of-date medicines and improper disposal of pharmaceutical products harm consumers and environment. To limit pharmaceutical load on the environment, it is important that healthcare professionals (HCPs) are aware of and have good practices toward their disposal. MATERIALS AND METHODS: A pretested instructor administered questionnaire containing 21 questions was used to assess knowledge, attitude, and practices (KAP) of 300 HCPs toward use and disposal of unwanted/expired medicines...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28034518/sex-effect-on-average-bioequivalence
#4
Manuel Ibarra, Marta Vázquez, Pietro Fagiolino
PURPOSE: Generic formulations are by far the most prescribed drugs. This scenario is highly beneficial for society because medication expenses are significantly reduced after expiration of the exclusivity period conceded to the branded name drug. Correspondingly, these formulations must be adequately evaluated to avoid drug inefficacy and toxicity in the overall patient population. Bioequivalence studies are the only in vivo evaluation that a generic drug must overcome to reach the market...
December 26, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/28033700/brucellosis-with-multi-organ-involvement-in-a-patient-with-history-of-composite-aortic-graft-and-hepatitis-b
#5
Seyed Ali Dehghan Manshadi, Omid Rezahosseini, Zahra Abdi Liaei
The brucellosis with multi-organ involvement in a patient with a history of the composite aortic graft (Bentall procedure) and Hepatitis B infection is rare. A 35-year-old man presented to us with fever and loss of consciousness. Four years ago, he was IDU and underwent cardiac surgery because of endocarditis. Recently lumbar spondylodiscitis was diagnosed. The Wright (1/320) and Coombs Wright tests (1/640) were positive. After CNS imaging, lumbar puncture was done. The CSF pleocytosis was lymphocyte dominant...
November 2016: Acta Medica Iranica
https://www.readbyqxmd.com/read/28012020/product-safety-spillovers-and-market-viability-for-biologic-drugs
#6
John Romley, Tiffany Shih
When a pharmaceutical manufacturer experiences a safety problem, negative impacts on profitability can spread to its competitors. Reduced consumer confidence, product recalls, and litigation are limited to the responsible manufacturer only if that manufacturer can be clearly linked to the safety problem. We analyze the impact of "accountability" for safety problems on manufacturer entry decisions and investments to mitigate risk. Consistent with prior research, we find investment levels increase with accountability in a duopoly market, and that accountability can thus enhance market viability and improve consumer welfare...
December 23, 2016: Int J Health Econ Manag
https://www.readbyqxmd.com/read/27940634/effectiveness-of-medicines-authentication-technology-to-detect-counterfeit-recalled-and-expired-medicines-a-two-stage-quantitative-secondary-care-study
#7
Bernard Naughton, Lindsey Roberts, Sue Dopson, Stephen Chapman, David Brindley
OBJECTIVES: To identify the authentication and detection rate of serialised medicines using medicines authentication technology. DESIGN AND INTERVENTION: 4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure external database cross-checking, triggered by the scanning of a two-dimensional data matrix with a unit specific 12-digit serial code. 4% of medicines included were preprogrammed with a message to identify the product as either expired, pack recalled, product recalled or counterfeit...
December 9, 2016: BMJ Open
https://www.readbyqxmd.com/read/27922254/comparison-of-two-different-forms-of-sevoflurane-for-anaesthesia-maintenance-and-recovery
#8
Yonca Yanli, Mehtap Ozdemir, Nurten Bakan, Cafer T Yuruk, Ahmet Yildirim, Ali O Cetinkaya
BACKGROUND: Sevoflurane is a commonly used inhalation agent. There are two forms of sevoflurane in Turkey. The aim of this study was to evaluate the effects of original versus generic sevoflurane products on hemodynamics, time to reach 1 MAC level, inspired and expired sevoflurane levels and postoperative recovery profile. METHODS: Seventy patients undergoing general anaesthesia were divided into two groups as Group Sevo or Group Sojo. After intravenous induction of anaesthesia (with the same drugs in both groups), inhalation anaesthetic was started...
December 6, 2016: Minerva Anestesiologica
https://www.readbyqxmd.com/read/27913790/do-cigarette-graphic-warnings-encourage-smokers-to-attend-a-smoking-cessation-programme-a-quasi-experimental-study
#9
Joseph Guydish, Barbara Tajima, Thao Le, Catherine Henderson, Deborah Yip, Valerie Gruber, Wayne Garcia, Kevin L Delucchi
OBJECTIVE: This study assessed whether exposure to cigarette graphic warning labels (GWLs) increased attendance to a smoking cessation programme. METHOD: From 2014 to 2016, alternating cohorts of smokers in 3 residential drug treatment programmes received either GWLs (experimental) or transparent (control) labels placed on their cigarette packs for 30 days. The primary outcome was the proportion of participants who chose to attend a smoking cessation group after the labelling period...
December 2, 2016: Tobacco Control
https://www.readbyqxmd.com/read/27883912/development-of-potential-candidate-reference-materials-for-drugs-in-bottom-sediment-cod-and-herring-tissues
#10
Irena Baranowska, Bogusław Buszewski, Jacek Namieśnik, Piotr Konieczka, Sylwia Magiera, Halina Polkowska-Motrenko, Paweł Kościelniak, Renata Gadzała-Kopciuch, Aneta Woźniakiewicz, Zbigniew Samczyński, Kinga Kochańska, Małgorzata Rutkowska
Regular use of a reference material and participation in a proficiency testing program can improve the reliability of analytical data. This paper presents the preparation of candidate reference materials for the drugs metoprolol, propranolol, carbamazepine, naproxen, and acenocoumarol in freshwater bottom sediment and cod and herring tissues. These reference materials are not available commercially. Drugs (between 7 ng/g and 32 ng/g) were added to the samples, and the spiked samples were freeze-dried, pulverized, sieved, homogenized, bottled, and sterilized by γ-irradiation to prepare the candidate materials...
February 2017: Chemosphere
https://www.readbyqxmd.com/read/27881996/quality-of-drug-stores-storage-practices-regulatory-compliance-in-karachi-pakistan
#11
Syed Shaukat Ali Muttaqi Shah, Baqar Shyum Naqvi, Mashhad Fatima, Asif Khaliq, Abdul Latif Sheikh, Muhammad Baqar
OBJECTIVE: To assess and evaluate the drug storage quality and regulatory compliance among privately operated drug stores of Karachi Pakistan. METHODS: A cross-sectional survey of drug stores located in Karachi was conducted from May to December 2013. A total of 1003 drug stores that were involved in the sales, purchase and dispensing of pharmaceutical products were approached by non-probability purposive sampling technique, and the information was collected using a close ended, structured questionnaire...
September 2016: Pakistan Journal of Medical Sciences Quarterly
https://www.readbyqxmd.com/read/27872408/active-expiration-and-the-measurement-of-central-venous-pressure
#12
Sheldon Magder, Karim Serri, Sara Verscheure, Renée Chauvin, Peter Goldberg
PURPOSE: To obtain a point prevalence estimate of alterations in central venous pressure (CVP) produced by active expiration in a consecutive series of intensive care patients. METHODS: We evaluated CVP tracings taken by the nurses at their morning shift change in a consecutive series of 60 cardiac surgery and 59 noncardiac surgery patients. We also assessed change in values due to the change in transducer level. Three physicians and a nurse instructor independently reviewed the tracings and determined whether there was evidence of forced expiration and whether it was type A, defined by decreasing CVP during expiration, or type B, defined by increasing CVP during expiration...
November 20, 2016: Journal of Intensive Care Medicine
https://www.readbyqxmd.com/read/27832357/emerging-biologics-in-inflammatory-bowel-disease
#13
REVIEW
Heyson Chi-Hey Chan, Siew Chien Ng
Early biologic therapy is recommended in patients with inflammatory bowel disease and poor prognostic factors and in those refractory to conventional medications. Anti-tumor necrosis factor (anti-TNF) agents are the most commonly used biologic agents. However, some patients may not have an initial response to anti-TNF therapy, and one-third will develop loss of response over time. Anti-TNF drugs can also be associated with side effects. In addition, the use of biologics is currently limited by their cost, especially in developing countries...
November 10, 2016: Journal of Gastroenterology
https://www.readbyqxmd.com/read/27815558/in-vitro-effects-of-an-extracorporeal-membrane-oxygenation-circuit-on-the-sequestration-of-%C3%AF%C2%B5-aminocaproic-acid
#14
Deborah Wagner, Miguel Caraballo, John Waldvogel, Yuki Peterson, Duxin Sun
OBJECTIVE: To assess the in vitro effects of drug sequestration in extracorporeal membrane oxygenation (ECMO) on ϵ-aminocaproic acid (EACA) concentrations. METHODS AND DESIGN: This in vitro study will determine changes in EACA concentration over time in ECMO circuits. A pediatric dose of 2,500 mg was administered to whole expired blood in the simulated pediatric ECMO circuit. Blood samples were collected at 0, 30, 60, 360 and 1440-minute intervals after initial administration equilibration from three different sites of the circuit: pre-oxygenator (PRE), post-oxygenator (POST) and PVC tubing (PVC) to determine the predominant site of drug loss...
November 3, 2016: Perfusion
https://www.readbyqxmd.com/read/27814325/fatal-cardiac-arrest-in-2-children-possible-role-of-ondansetron
#15
Scott M Brenner, Jenny Boucher
INTRODUCTION: Ondansetron is commonly used to treat vomiting in gastroenteritis, but has a United States Food and Drug Administration black box warning for risk of Q wave to T wave time interval (QT) prolongation. We report 2 pediatric cases of fatal refractory cardiac arrest after administration of ondansetron. CASES: A 10-year-old previously healthy boy presented to the emergency room with gastroenteritis symptoms. After intravenous fluids, morphine, antibiotics, and 2 doses of ondansetron, the patient became unresponsive with agonal respirations and a wide complex tachycardia consistent with ventricular tachycardia...
November 2016: Pediatric Emergency Care
https://www.readbyqxmd.com/read/27783703/the-impact-of-methylenetetrahydrofolate-reductase-c677t-polymorphism-on-patients-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-with-methotrexate-prophylaxis
#16
Ja Min Byun, Hea-Lim Kim, Dong-Yeop Shin, Youngil Koh, Sung-Soo Yoon, Moon-Woo Seong, Sung Sup Park, Jin Hee Kim, Yun-Gyoo Lee, Inho Kim
Pharmacogenomics can explain the inter-individual differences in response to drugs, including methotrexate (MTX) used for acute graft-versus-host disease (aGVHD) prophylaxis during hematopoietic stem cell transplantation (HSCT). In real-world practice, preplanned MTX dose is arbitrarily modified according to observed toxicity which can lead to unexpected and severe aGVHD development. We aimed to validate the influence of MTHFR C677T polymorphism on the outcomes of allogenic HSCT in a relatively under-represented homogenous Asian population...
2016: PloS One
https://www.readbyqxmd.com/read/27781100/how-can-we-achieve-universal-access-to-low-cost-treatment-for-hiv
#17
EDITORIAL
Andrew M Hill, Anton L Pozniak
Mass production of low-cost antiretrovirals (ARVs) has already allowed over 17 million individuals to access treatment for HIV infection, mainly in low-income countries. It is possible to manufacture combination ARVs for $110 per person-year, using tenofovir (TDF), lamivudine (3TC) and efavirenz (EFV). New combinations of ARVs costing as little as $60 per person-year will be available in the near future. Pre-exposure prophylaxis using TDF in combination with either 3TC or emtricitabine (FTC) could also be provided for less than $90 per person-year...
October 5, 2016: Journal of Virus Eradication
https://www.readbyqxmd.com/read/27770719/epilepsy-with-myoclonic-absences-electroclinical-characteristics-in-a-distinctive-pediatric-epilepsy-phenotype
#18
Paresh Zanzmera, Ramshekhar N Menon, Kalyani Karkare, Himanshu Soni, Sujit Jagtap, Ashalatha Radhakrishnan
PURPOSE: The purpose of this article was to study the electroclinical characteristics and seizure outcome of children with epilepsy with myoclonic absences (EMA). METHOD: In this descriptive cohort study, we reviewed clinical records of patients who met the criteria for EMA. Each patient's demographic data, birth/developmental history, seizure semiology/pattern, antiepileptic drugs (AED), clinical examination, video-electroencephalography (VEEG), and neuroimaging data were reviewed...
October 19, 2016: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/27766144/household-medical-waste-disposal-policy-in-israel
#19
Zohar Barnett-Itzhaki, Tamar Berman, Itamar Grotto, Eyal Schwartzberg
BACKGROUND: Large amounts of expired and unused medications accumulate in households. This potentially exposes the public to hazards due to uncontrolled use of medications. Most of the expired or unused medications that accumulate in households (household medical waste) is thrown to the garbage or flushed down to the sewage, potentially contaminating waste-water, water resources and even drinking water. There is evidence that pharmaceutical active ingredients reach the environment, including food, however the risk to public health from low level exposure to pharmaceuticals in the environment is currently unknown...
2016: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/27709905/complete-molecular-weight-profiling-of-low-molecular-weight-heparins-using-size-exclusion-chromatography-ion-suppressor-high-resolution-mass-spectrometry
#20
Joseph Zaia, Kshitij Khatri, Joshua Klein, Chun Shao, Yuewei Sheng, Rosa Viner
Low-molecular weight heparins (LMWH) prepared by partial depolymerization of unfractionated heparin are used globally to treat coagulation disorders on an outpatient basis. Patent protection for several LMWH has expired and abbreviated new drug applications have been approved by the Food and Drug Administration. As a result, reverse engineering of LMWH for biosimilar LMWH has become an active global endeavor. Traditionally, the molecular weight distributions of LMWH preparations have been determined using size exclusion chromatography (SEC) with optical detection...
November 1, 2016: Analytical Chemistry
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