Search for long-lived doubly charged Higgs bosons in p(p)over-bar collisions at root s=1.96 TeV

We present a search for long-lived doubly charged Higgs bosons (H+/-+/-), with signatures of high ionization energy loss and muonlike penetration. We use 292 pb(-1) of data collected in p (p) over bar collisions at root s=1.96 TeV by the CDF II detector at the Fermilab Tevatron. Observing no evidence of long-lived doubly charged particle production, we exclude H-L(+/-+/-) and H-R(+/-+/-) bosons with masses below 133 GeV/c(2) and 109 GeV/c(2), respectively. In the degenerate case we exclude H+/-+/- mass below 146 GeV/c(2). All limits are quoted at the 95% confidence level

Measurement of the W+W- Production Cross Section in ppbar Collisions at sqrt(s)=1.96 TeV using Dilepton Events

We present a measurement of the W+W- production cross section using 184/pb of ppbar collisions at a center-of-mass energy of 1.96 TeV collected with the Collider Detector at Fermilab. Using the dilepton decay channel W+W- -> l+l-vvbar, where the charged leptons can be either electrons or muons, we find 17 candidate events compared to an expected background of 5.0+2.2-0.8 events. The resulting W+W- production cross section measurement of sigma(ppbar -> W+W-) = 14.6 +5.8 -5.1 (stat) +1.8 -3.0 (syst) +-0.9 (lum) pb agrees well with the Standard Model expectation.Comment: 8 pages, 2 figures, 2 tables. To be submitted to Physical Review Letter

Опыт регулирования генетических технологий в сфере охраны здоровья

Engineering of gene therapy products involves additional risks to humans and the environment. Legal regulation must adhere to additional control beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of gene therapy products and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which gene therapy products fall in the United States, the European Union, and People's Republic of China, in the Eurasian Economic Union and a small overview of the regulatory guidance applicable to the developer of gene and cell therapy, and gene-modified organism products. Understanding the regulatory requirements for drugs in this area are crucial both for patient safety and for quickly entering to the market highly competitive gene and cell therapy products.Разработка продуктов генной терапии подразумевает под собой дополнительные риски для человека и окружающей среды. Нормативно-правовое регулирование должно придерживаться дополнительной регуляции, выходящей за рамки традиционной низкомолекулярной терапии, благодаря уникальному механизму действия генной терапии и возникающим в результате новым рискам. Мы предоставили здесь краткое изложение структуры регулирования, в соответствии с которой регистрируются препараты генной и клеточной терапии Соединенных Штатах Америки, Европейском Союзе, Китае, на территории Евразийского экономического союза, а также обзор нормативных документов, применимых к разработчику генных продуктов и генно-модифицированных организмов. Понимание нормативных требований для препаратов в этой области имеет решающее значение как для обеспечения безопасности пациентов, так и для быстрого выхода на рынок высококонкурентных продуктов генной и клеточной терапии

Off-label structure of drugs prescription for children: An analysis of the Russian spontaneous reports database

The use of medicinal products (MP) with contraventions of officially approved instructions regulations (off-label), especially in pediatrics, is an actual problem of health care. This article studies MP off-label use structure in children and role of such drugs use in development of serious adverse reactions (AR), on the basis of Russian spontaneous reports database analysis. The results confirm that off -label MP prescription is an independent factor for AR developing risk. The study proved that spontaneous reports method is effective in studying of medicines use security problems and allows to develop recommendations that can significantly reduce the risk of pharmacotherapy complications, including in pediatric patients. © 2016, Pediatria Ltd. All rights reserved

Monitoring of adverse reactions on medicines in children in the Russian federation

Objective of the research - to study safety of medicinal preparations (MP) for children by analyzing a Roszdravnadzor national database of spontaneous reports (SR). This study includes a retrospective analysis of 467 primary SR on severe adverse reactions (AR) in children recorded to database in 2015. Children of preschool age have higher risk of medical therapy complications. Most frequently, skin and whole body (38,7% and 21,1%, respectively) were involved in the pathological process. Unexpected AR were identified in children in 10,8% of cases. They were often caused by antimicrobial system action drugs (43,8%) and drugs for nervous system treatment (26,1%). SR method allows to obtain new information about MP safety in the pediatric population, and to develop measures to reduce risks of medical therapy. © 2017, Pediatria Ltd. All rights reserved

Off-label structure of drugs prescription for children: An analysis of the Russian spontaneous reports database

The use of medicinal products (MP) with contraventions of officially approved instructions regulations (off-label), especially in pediatrics, is an actual problem of health care. This article studies MP off-label use structure in children and role of such drugs use in development of serious adverse reactions (AR), on the basis of Russian spontaneous reports database analysis. The results confirm that off -label MP prescription is an independent factor for AR developing risk. The study proved that spontaneous reports method is effective in studying of medicines use security problems and allows to develop recommendations that can significantly reduce the risk of pharmacotherapy complications, including in pediatric patients. © 2016, Pediatria Ltd. All rights reserved

Различия в инструкциях как причина ошибок при применении лекарственных препаратов

Contradictions in drug labeling texts for various medicinal products with the same active substance can cause medication errors. We found discrepancies in the Russian drug labeling texts for cefotaxime and oral forms of amoxicillin/clavulanic acid, 500 + 125 mg. We analyzed the Russian database of spontaneous reports. In 18.5% spontaneous reports with cefotaxime as a suspected drug and in 22.0% spontaneous reports with amoxicillin/clavulanate in forms for an oral administration as a suspected drug we detected medication errors resulted from deviations from those items of approved drug labels which were not harmonized for different drug manufacturers. Such problems require the participation of regulatory authorities in order to eliminate existing discrepancies.Расхождение информации в отдельных разделах инструкций по медицинскому применению лекарственных препаратов с одним действующим веществом но разных производителей сопровождается риском совершения медицинских ошибок. В инструкциях по применению лекарственных препаратов с действующим веществом цефотаксим и пероральных форм препаратов с действующим веществом амоксициллин/ клавулановая кислота в дозировке 500+125 мг имелись различия. При этом при анализе спонтанных сообщений, поступивших в российскую национальную базу данных, в 18,5% извещений о нежелательных реакциях при применении цефотаксима, и 22,0% извещений о нежелательных реакциях при применении пероральных форм амоксициллина/клавуланата, 500+125 мг, были выявлены ошибки, которые заключались в несоблюдении тех пунктов инструкций, информация в которых не была унифицирована. Подобные проблемы требуют участия регуляторных органов для устранения существующих противоречий

Monitoring of adverse reactions on medicines in children in the Russian federation

Objective of the research - to study safety of medicinal preparations (MP) for children by analyzing a Roszdravnadzor national database of spontaneous reports (SR). This study includes a retrospective analysis of 467 primary SR on severe adverse reactions (AR) in children recorded to database in 2015. Children of preschool age have higher risk of medical therapy complications. Most frequently, skin and whole body (38,7% and 21,1%, respectively) were involved in the pathological process. Unexpected AR were identified in children in 10,8% of cases. They were often caused by antimicrobial system action drugs (43,8%) and drugs for nervous system treatment (26,1%). SR method allows to obtain new information about MP safety in the pediatric population, and to develop measures to reduce risks of medical therapy. © 2017, Pediatria Ltd. All rights reserved