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Post marketing surveillance

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https://www.readbyqxmd.com/read/29429483/a-cost-benefit-analysis-and-the-potential-trade-effects-of-the-bovine-viral-diarrhoea-eradication-programme-in-styria-austria
#1
T Marschik, W Obritzhauser, P Wagner, V Richter, M Mayerhofer, C Egger-Danner, A Käsbohrer, B Pinior
This study evaluated the voluntary and compulsory implementation of a bovine viral diarrhoea virus (BVDV) eradication programme in the Austrian Federal State of Styria, Austria, from an economic point of view using ex-post assessment of costs and benefits (disease losses avoided). An economic net benefit (benefit:cost ratio, BCR=1.18) of the programme was demonstrated during the voluntary programme phase (January 1998-July 2004). The break-even point was reached in 2003. If investments in the compulsory programme (August 2004-December 2016) were taken into account, a net economic loss (BCR=0...
January 2018: Veterinary Journal
https://www.readbyqxmd.com/read/29428441/the-role-of-external-quality-assessment-in-the-verification-of-in-vitro-medical-diagnostics-in-the-traceability-era
#2
Federica Braga, Sara Pasqualetti, Mauro Panteghini
Once an in-vitro diagnostic (IVD) measuring system has been marketed and introduced into daily practice, the possible sources of degradation of its performance are numerous. It is therefore essential to put in place a continuous post-market surveillance of the quality of performance of the IVD system and of the laboratories that perform measurements in clinical setting. The participation to external quality assessment (EQA) schemes that meet specific metrological criteria is central to the evaluation of performance of clinical laboratories in terms of standardization and clinical suitability of their measurements...
February 8, 2018: Clinical Biochemistry
https://www.readbyqxmd.com/read/29425340/clinical-review-of-delafloxacin-a-novel-anionic-fluoroquinolone
#3
Bryan T Mogle, Jeffrey M Steele, Stephen J Thomas, KarenBeth H Bohan, Wesley D Kufel
Delafloxacin is a novel anionic fluoroquinolone (FQ) approved for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by a number of Gram-positive and Gram-negative organisms including MRSA and Pseudomonas aeruginosa. The unique chemical structure of delafloxacin renders it a weak acid and results in increased potency in acidic environments. In Phase III studies, delafloxacin had similar outcomes to comparator regimens for treatment of ABSSSIs, and was well tolerated overall. Similar to other FQs, delafloxacin is available in both intravenous and oral formulations, but differs in that delafloxacin exerts a minimal effect on cytochrome P450 enzymes and on the corrected QT interval...
February 7, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29415382/one-year-outcomes-after-rapid-deployment-aortic-valve-replacement
#4
Christopher Young, Günther Laufer, Alfred Kocher, Marco Solinas, Francesco Alamanni, Gianluca Polvani, Bruno K Podesser, Jose Ignacio Aramendi, Jose Arribas, Olivier Bouchot, Ugolino Livi, Massimo Massetti, Kim Terp, Christophe Giot, Mattia Glauber
OBJECTIVE: The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). METHODS: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system...
February 2018: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29412117/strategies-empowering-paediatric-drug-safety
#5
Marta Gentili, Marco Pozzi, Gabrielle Peeters, Sonia Radice, Carla Carnovale
Background Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterise fully the safety profiles of drugs. Addionally, information about rare adverse drug reactions (ADRs) in special groups or drug-drug interactions (DDIs) is often incomplete or not available for most of the drugs commonly used in the daily clinical practice...
February 6, 2018: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/29402465/-topical-cyclosporine-a-and-risk-of-ocular-surface-neoplasia
#6
F Rouimi, A Bouillot, C Baudouin, A Labbé
INTRODUCTION: Cyclosporine A (CsA) has well-known cutaneous carcinogenic effects when administered systemically. In ophthalmology, it is increasingly used in the form of eye drops since its indication for moderate to severe eye dry eye. The goal of this review of the literature is to evaluate a possible link between topical ocular CsA use and the occurrence of ocular surface neoplasia. MATERIALS AND METHODS: A literature review was performed. Publications evaluating the safety and efficacy of topical CsA as well as studies on the epidemiology and risk factors for conjunctival neoplasia and cases of conjunctival neoplasia were analyzed...
February 2, 2018: Journal Français D'ophtalmologie
https://www.readbyqxmd.com/read/29398477/clinical-safety-and-efficacy-of-filgrastim-biosimilar-2-in-japanese-patients-in-a-post-marketing-surveillance-study
#7
Kazuo Tamura, Kazue Hashimoto, Kiyohiro Nishikawa
We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5...
February 2, 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
https://www.readbyqxmd.com/read/29391822/post-marketing-surveillance-study-of-the-safety-and-efficacy-of-nalfurafine-hydrochloride-remitch%C3%A2-capsules-2-5-%C3%AE-g-in-3-762-hemodialysis-patients-with-intractable-pruritus
#8
Hideki Kozono, Hiroshi Yoshitani, Ryoko Nakano
Background: Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis...
2018: International Journal of Nephrology and Renovascular Disease
https://www.readbyqxmd.com/read/29386432/-adverse-effect-predictions-based-on-computational-toxicology-techniques-and-large-scale-databases
#9
Yoshihiro Uesawa
 Understanding the features of chemical structures related to the adverse effects of drugs is useful for identifying potential adverse effects of new drugs. This can be based on the limited information available from post-marketing surveillance, assessment of the potential toxicities of metabolites and illegal drugs with unclear characteristics, screening of lead compounds at the drug discovery stage, and identification of leads for the discovery of new pharmacological mechanisms. This present paper describes techniques used in computational toxicology to investigate the content of large-scale spontaneous report databases of adverse effects, and it is illustrated with examples...
2018: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/29383624/effects-of-eculizumab-treatment-on-quality-of-life-in-patients-with-paroxysmal-nocturnal-hemoglobinuria-in-japan
#10
Yasutaka Ueda, Naoshi Obara, Yuji Yonemura, Hideyoshi Noji, Masayoshi Masuko, Yoshinobu Seki, Katsuya Wada, Takahisa Matsuda, Hirozumi Akiyama, Takayuki Ikezoe, Shigeru Chiba, Yoshinobu Kanda, Tatsuya Kawaguchi, Tsutomu Shichishima, Hideki Nakakuma, Shinichiro Okamoto, Jun-Ichi Nishimura, Yuzuru Kanakura, Haruhiko Ninomiya
In paroxysmal nocturnal hemoglobinuria (PNH), various symptoms due to intravascular hemolysis exert a negative impact on patients' quality of life (QOL). To determine clinical factors related with improvements in QOL in PNH patients treated, we analyzed changes in QOL scales in PNH patients treated with eculizumab based on data collected from post-marketing surveillance in Japan. Summary statistics were obtained using figures from QOL scoring systems and laboratory values, and evaluated by t test. One-year administration of eculizumab improved the most QOL items in comparison with the baseline...
January 30, 2018: International Journal of Hematology
https://www.readbyqxmd.com/read/29379048/an-mcem-framework-for-drug-safety-signal-detection-and-combination-from-heterogeneous-real-world-evidence
#11
Cao Xiao, Ying Li, Inci M Baytas, Jiayu Zhou, Fei Wang
Delayed drug safety insights can impact patients, pharmaceutical companies, and the whole society. Post-market drug safety surveillance plays a critical role in providing drug safety insights, where real world evidence such as spontaneous reporting systems (SRS) and a series of disproportional analysis serve as a cornerstone of proactive and predictive drug safety surveillance. However, they still face several challenges including concomitant drugs confounders, rare adverse drug reaction (ADR) detection, data bias, and the under-reporting issue...
January 29, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29364585/what-have-we-learnt-from-real-world-data-observational-studies-and-meta-analyses
#12
REVIEW
Sudesna Chatterjee, Melanie J Davies, Kamlesh Khunti
The incretin therapies glucagon-like peptide-1 receptor agonists (GLP-1 RA) and dipeptidyl peptidase-IV (DPP-IV) inhibitors are now well-established as second and third-line therapies and in combination with insulin for the treatment of type 2 diabetes. Over the last decade, there is accumulating evidence of their efficacy and safety from both large multicentre randomized clinical trials (RCT) and observational studies. Cardiovascular outcome trials have confirmed that several of these agents are also non-inferior to placebo with the GLP-1 RA liraglutide and semaglutide recently found to be superior in terms of major adverse cardiovascular events...
February 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29336924/immunization-of-preterm-infants-with-gsk-s-hexavalent-combined-diphtheria-tetanus-acellular-pertussis-hepatitis-b-inactivated-poliovirus-haemophilus-influenzae-type-b-conjugate-vaccine-a-review-of-safety-and-immunogenicity
#13
Felix Omeñaca, Liliana Vázquez, Pilar Garcia-Corbeira, Narcisa Mesaros, Linda Hanssens, Jan Dolhain, Ivonne Puente Gómez, Johannes Liese, Markus Knuf
BACKGROUND: Infants with history of prematurity (<37 weeks gestation) and low birth weight (LBW, <2500 g) are at high risk of infection due to functional immaturity of normal physical and immunological defense mechanisms. Despite current recommendations that infants with history of prematurity/LBW should receive routine immunization according to the same schedule and chronological age as full-term infants, immunization is often delayed. METHODS: Here we summarize 10 clinical studies and 15 years of post-marketing safety surveillance of GSK's hexavalent vaccine (DTPa-HBV-IPV/Hib), a combined diphtheria-tetanus-acellular-pertussis-hepatitis-B-inactivated-poliovirus-Haemophilus influenzae-type-b (Hib) conjugate vaccine, when administered alone, or co-administered with pneumococcal conjugate, rotavirus, and meningococcal vaccines and respiratory syncytial virus IgG to infants with history of prematurity/LBW in clinical trials...
January 11, 2018: Vaccine
https://www.readbyqxmd.com/read/29325687/clinical-significance-and-epidemiologic-analyses-of-mycobacterium-avium-and-mycobacterium-intracellulare-lung-disease-from-post-marketing-surveillance
#14
Katsuhiro Suzuki, Atsuyuki Kurashima, Kinji Tatsuno, Jun-Ichi Kadota
BACKGROUND: In Japan, nontuberculous mycobacterial lung disease is mostly attributable to Mycobacterium avium complex (MAC), i.e., M. avium or M. intracellulare. However, clinical features of the disease caused by these two pathogens have not been studied sufficiently yet. METHODS: A post-marketing survey of clarithromycin was performed at 130 facilities across Japan. The data on patients with M. avium infection and patients with M. intracellulare infection were selected from this survey for comparison of background variables and clinical features of the two pathogens...
January 2018: Respiratory Investigation
https://www.readbyqxmd.com/read/29307089/genetic-and-biological-characterization-of-three-poultry-origin-h5n6-avian-influenza-viruses-with-all-internal-genes-from-genotype-s-h9n2-viruses
#15
Kaituo Liu, Min Gu, Shunlin Hu, Ruyi Gao, Juan Li, Liwei Shi, Wenqi Sun, Dong Liu, Zhao Gao, Xiulong Xu, Jiao Hu, Xiaoquan Wang, Xiaowen Liu, Sujuan Chen, Daxin Peng, Xinan Jiao, Xiufan Liu
During surveillance for avian influenza viruses, three H5N6 viruses were isolated in chickens obtained from live bird markets in eastern China, between January 2015 and April 2016. Sequence analysis revealed a high genomic homology between these poultry isolates and recent human H5N6 variants whose internal genes were derived from genotype S H9N2 avian influenza viruses. Glycan binding assays revealed that all avian H5N6 viruses were capable of binding to both human-type SAα-2,6Gal receptors and avian-type SAα-2,3Gal receptors...
January 6, 2018: Archives of Virology
https://www.readbyqxmd.com/read/29303999/comparative-evaluation-of-u-s-brand-and-generic-intravenous-sodium-ferric-gluconate-complex-in-sucrose-injection-physicochemical-characterization
#16
Dajun Sun, Rodney Rouse, Vikram Patel, Yong Wu, Jiwen Zheng, Alokita Karmakar, Anil K Patri, Priyanka Chitranshi, David Keire, Jia Ma, Wenlei Jiang
The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit) and generic sodium ferric gluconate (SFG) in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC) and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS)...
January 5, 2018: Nanomaterials
https://www.readbyqxmd.com/read/29298186/evaluation-of-the-relative-abuse-of-an-oros%C3%A2-extended-release-hydromorphone-hci-product-results-from-three-post-market-surveillance-studies
#17
Stephen F Butler, Emily C McNaughton, Ryan A Black, Theresa A Cassidy
OBJECTIVE: Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. METHODS: Estimates of abuse, unadjusted and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data...
January 2, 2018: Clinical Journal of Pain
https://www.readbyqxmd.com/read/29282676/surveillance-on-the-safety-and-efficacy-of-ambrisentan-volibris-tablet-2-5-mg-in-patients-with-pulmonary-arterial-hypertension-in-real-clinical-practice-post-marketing-surveillance-interim-analysis-report
#18
Tomohiko Takahashi, Satoru Hayata, Akihiro Kobayashi, Yuna Onaka, Takeshi Ebihara, Terufumi Hara
BACKGROUND AND OBJECTIVE: Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. METHODS: PAH patients aged 15 years or older were subjected to the analysis...
December 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29250905/validity-of-diagnostic-codes-to-identify-hospitalizations-for-infections-among-patients-treated-with-oral-anti-diabetic-drugs
#19
M Elle Saine, Mona Gizaw, Dena M Carbonari, Craig W Newcomb, Jason A Roy, Serena Cardillo, Daina B Esposito, Harshvinder Bhullar, Arlene M Gallagher, Brian L Strom, Vincent Lo Re
PURPOSE: Identification of hospitalizations for infection is important for post-marketing surveillance of drugs, but the validity of using diagnosis codes to identify these events is unknown. Differentiating between hospitalization for and with infection is important, as the latter is common and less likely to arise from pre-admission exposure to drugs. We determined positive predictive values (PPVs) of diagnostic coding-based algorithms to identify hospitalization for infection among patients prescribed oral anti-diabetic drugs (OADs)...
December 18, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29241390/public-health-impact-of-pneumococcal-conjugate-vaccine-infant-immunization-programs-assessment-of-invasive-pneumococcal-disease-burden-and-serotype-distribution
#20
Patricia Izurieta, Priti Bahety, Richard Adegbola, Christopher Clarke, Bernard Hoet
Introduction Pneumococcal conjugate vaccine (PCV) impact studies have reported substantial reductions in the incidence of invasive pneumococcal disease (IPD) after implementation of childhood PCV programs. Heterogeneity in surveillance systems, local epidemiology and PCV programs hampers comparisons between studies. We aimed to better understand the impact of childhood PCV programs on overall IPD and serotype distribution. Areas covered We analyzed the impact of PCV programs on the incidence of overall IPD, and the distribution of vaccine serotypes (VT) and non-vaccine serotypes (NVT) in children <5 years and adults ≥65 years old...
December 15, 2017: Expert Review of Vaccines
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