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https://www.readbyqxmd.com/read/28100464/six-month-market-exclusivity-extensions-to-promote-research-offer-substantial-returns-for-many-drug-makers
#1
Aaron S Kesselheim, Benjamin N Rome, Ameet Sarpatwari, Jerry Avorn
To incentivize pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending the market exclusivity period of desired drugs. Some such proposals are modeled after the pediatric exclusivity patent extension program, which since 1997 has provided six additional months of market exclusivity for drugs studied in children. The most recent proposal would encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication...
January 18, 2017: Health Affairs
https://www.readbyqxmd.com/read/28098941/posterior-cortex-epilepsy-surgery-in-childhood-and-adolescence-predictors-of-long-term-seizure-outcome
#2
Georgia Ramantani, Angeliki Stathi, Armin Brandt, Karl Strobl, Susanne Schubert-Bast, Gert Wiegand, Rudolf Korinthenberg, Vera van Velthoven, Josef Zentner, Andreas Schulze-Bonhage, Thomas Bast
OBJECTIVE: We aimed to investigate the long-term seizure outcome of children and adolescents who were undergoing epilepsy surgery in the parietooccipital cortex and determine their predictive factors. METHODS: We retrospectively analyzed the data of 50 consecutive patients aged 11.1 (mean) ± 5.1 (standard deviation) years at surgery. All patients but one had a magnetic resonance imaging (MRI)-visible lesion. Resections were parietal in 40%, occipital in 32%, and parietooccipital in 28% cases; 24% patients additionally underwent a resection of the posterior border of the temporal lobe...
January 18, 2017: Epilepsia
https://www.readbyqxmd.com/read/28098869/core%C3%A2-shell-lipid-polymer-nanoparticles-for-combined-chemo%C3%A2-and-gene-therapy-of-childhood-head-and-neck-cancers
#3
Tiesong Zhang, Jing Ma, Chao Li, Ken Lin, Fan Lou, Hongchao Jiang, Yingqin Gao, Yanli Yang, Cheng Ming, Biao Ruan
Pediatric head and neck cancers account for overall 12% of all pediatric cancers. Despite recent advances in therapeutic modalities, children with tumor metastasis have poor prognosis. Therefore, there is an unmet need for new and effective treatment modalities for pediatric head and neck cancers. The present study describes a simple and efficient method for fabrication of cationic lipid‑polymer hybrid nanoparticles (CLPNs) for co‑delivery of cisplatin (CDDP) and DNA (CDDP/DNA CLPNs) for the therapy of childhood head and neck cancers...
January 13, 2017: Oncology Reports
https://www.readbyqxmd.com/read/28098395/first-uhplc-ms-ms-method-coupled-with-automated-on-line-spe-for-quantification-both-of-tacrolimus-and-everolimus-in-peripheral-blood-mononuclear-cells-and-its-application-on-samples-from-co-treated-pediatric-patients
#4
Debora Pensi, Amedeo De Nicolò, Michele Pinon, Clarissa Pisciotta, Pier Luigi Calvo, Antonello Nonnato, Renato Romagnoli, Francesco Tandoi, Giovanni Di Perri, Antonio D'Avolio
Tacrolimus (TAC, FK-506) and everolimus (EVE, RAD001) are immunosuppressors used to treat pediatric patients undergoing liver transplantation. Their hematic TDM by liquid chromatography became standard practice. However, it does not always reflect concentrations at their active site. Our aim was to develop and validate a new method for the simultaneous TAC and EVE quantification into target cells: Peripheral-Blood-Mononuclear-Cells (PBMCs). PBMCs were collected using Cell-Preparation-Tubes; cells number and MCV were evaluated by an automatic cell counter...
January 18, 2017: Journal of Mass Spectrometry: JMS
https://www.readbyqxmd.com/read/28097858/-the-current-status-of-patient-safety-in-argentina-cross-sectional-study
#5
Lucrecia Arpí, Néstor D Panattieri, Cristina Godio, Verónica Sabio Paz, Nora Dackiewicz
BACKGROUND: Patient safety is a priority for healthcare organizations. For the PRONAP´s 2013 final exam, the Quality & Patient Safety Subcommittee and the PRONAP managers designed a survey to be answered by pediatrician students nationwide. It was destined to evaluate attitudes, practices and safety conditions in which they worked. AIM: To assess the current state of practices in patient safety. MATERIAL AND METHODS: Setting and sample: PRONAP students (7,438 pediatrician nationwide) who answered 2013 final exam...
1, 2017: Archivos Argentinos de Pediatría
https://www.readbyqxmd.com/read/28097808/identification-of-ntrk-fusions-in-pediatric-mesenchymal-tumors
#6
Dean Pavlick, Alexa B Schrock, Denise Malicki, Philip J Stephens, Dennis J Kuo, Hyunah Ahn, Brian Turpin, Kamran Badizegan, Jeffrey S Ross, Vincent A Miller, Victor Wong, Siraj M Ali
BACKGROUND: NTRK fusions are known oncogenic drivers and have recently been effectively targeted by investigational agents in adults. We sought to assess the frequency of NTRK fusions in a large series of pediatric and adolescent patients with advanced cancers. PROCEDURE: Genomic profiles from 2,031 advanced cancers from patients less than 21 years old who were assayed with comprehensive genomic profiling were reviewed to identify NTRK fusions. RESULTS: Total of nine cases (0...
January 18, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28097507/in-vitro-phase-i-and-phase-ii-drug-metabolism-in-the-liver-of-juvenile-and-adult-g%C3%A3-ttingen-minipigs
#7
Els Van Peer, Frank Jacobs, Jan Snoeys, Jos Van Houdt, Ils Pijpers, Christophe Casteleyn, Chris Van Ginneken, Steven Van Cruchten
PURPOSE: In view of pediatric drug development, juvenile animal studies are gaining importance. However, data on drug metabolizing capacities of juvenile animals are scarce, especially in non-rodent species. Therefore, we aimed to characterize the in vitro biotransformation of four human CYP450 substrates and one UGT substrate in the livers of developing Göttingen minipigs. METHODS: Liver microsomes from late fetal, Day 1, Day 3, Day 7, Day 28, and adult male and female Göttingen minipigs were incubated with a cocktail of CYP450 substrates, including phenacetin, tolbutamide, dextromethorphan, and midazolam...
January 17, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28096977/high-rates-of-multidrug-resistance-among-uropathogenic-escherichia-coli-in-children-and-analyses-of-esbl-producers-from-nepal
#8
Narayan Prasad Parajuli, Pooja Maharjan, Hridaya Parajuli, Govardhan Joshi, Deliya Paudel, Sujan Sayami, Puspa Raj Khanal
BACKGROUND: Emergence of Extended-spectrum beta-lactamase producing Escherichia coli causing urinary tract infections (UTI) among pediatric patients is an increasing problem worldwide. However, very little is known about pediatric urinary tract infections and antimicrobial resistance trend from Nepal. This study was conducted to assess the current antibiotic resistance rate and ESBL production among uropathogenic Escherichia coli in pediatric patients of a tertiary care teaching hospital of Nepal...
2017: Antimicrobial Resistance and Infection Control
https://www.readbyqxmd.com/read/28093933/acute-kidney-injury-in-idiopathic-nephrotic-syndrome-of-childhood-is-a-major-risk-factor-for-the-development-of-chronic-kidney-disease
#9
Afshan Yaseen, Vina Tresa, Ali Asghar Lanewala, Seema Hashmi, Irshad Ali, Sabeeta Khatri, Muhammed Mubarak
BACKGROUND: Acute kidney injury (AKI) is an important complication of idiopathic nephrotic syndrome (INS) and is associated with adverse outcomes, especially the development of chronic kidney disease (CKD). We aimed to determine the clinical profile of children with INS who developed AKI and its short-term outcome. MATERIAL AND METHODS: This prospective study was conducted from March 2014 to October 2015. A total of 119 children of INS (age: 2-18 years) fulfilling the pediatric RIFLE criteria for the diagnosis of AKI were enrolled and followed up for 3 months to determine the outcome...
November 2017: Renal Failure
https://www.readbyqxmd.com/read/28092280/challenges-and-opportunities-to-enhance-global-drug-development-in-neonates
#10
Alexandra M Smith, Jonathan M Davis
PURPOSE OF REVIEW: This study reviews the history of neonatal drug development, recent legislative efforts designed to facilitate the study of therapeutic agents in neonates, and future steps necessary to advance drug development. RECENT FINDINGS: Although many federal regulations have been introduced over the past 15 years to encourage pediatric and neonatal drug development, the majority of medications that are used in the Neonatal Intensive Care Unit are not approved by the Food and Drug Administration (FDA) for use in neonates...
January 13, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28090779/preparation-and-in-vitro-in-vivo-evaluation-of-metformin-hydrochloride-rectal-dosage-forms-for-treatment-of-patients-with-type-ii-diabetes
#11
Abdel-Azim Zaghloul, Ahmad Lila, Fathy Abd-Allah, Aly Nada
BACKGROUND: Metformin hydrochloride (MtHCL) is an oral antidiabetic drug and has many other therapeutic benefits. It has poor bioavailability, narrow absorption window and extensive liver metabolism. Moreover, children and elders face difficulty to swallow the commercial oral tablets. OBJECTIVES: Preparation, in vitro/in vivo evaluation of MtHCL suppositories for rectal administration to solve some of these problems. METHODS: Suppository fatty bases (Witepsol®, Suppocire® and Massa®; different grades) and PEG bases 1000, 4000 and 6000 (different ratios), were used to prepare rectal suppository formulations each containing 500 mg drug...
January 16, 2017: Journal of Drug Targeting
https://www.readbyqxmd.com/read/28089765/intracerebroventricular-delivery-as-a-safe-long-term-route-of-administration
#12
REVIEW
Jessica L Cohen-Pfeffer, Sridharan Gururangan, Thomas Lester, Daniel A Lim, Adam J Shaywitz, Manfred Westphal, Irene Slavc
Intrathecal delivery methods have been used for many decades to treat a broad range of central nervous system disorders. A literature review demonstrated that intracerebroventricular route is an established and well-tolerated method for prolonged central nervous system drug delivery in pediatric and adult populations. Intracerebroventricular devices were present in patients from one to 7156 days. The number of punctures per device ranged from 2 to 280. Noninfectious complication rates per patient (range, 1...
November 10, 2016: Pediatric Neurology
https://www.readbyqxmd.com/read/28088906/epratuzumab-and-blinatumomab-as-therapeutic-antibodies-for-treatment-of-pediatric-acute-lymphoblastic-leukemia-current-status-and-future-perspectives
#13
Raffaella Franca, Diego Favretto, Marilena Granzotto, Giuliana Decorti, Marco Rabusin, Gabriele Stocco
BACKGROUND: More than 85% of children affected by acute lymphoblastic leukemia (ALL) are successfully treated; however relapse remains a remarkable clinical concern, with 50-60% of relapsing patients facing a fatal outcome. Management of relapsed patients includes standardized intensive risk-adapted regimens based on conventional drugs, and hematopoietic stem cells transplantation for patients with unfavourable features. Biological drugs, in particular the monoclonal antibody epratuzumab and the bi-functional recombinant single chain peptide blinatumomab, have been recently recognized as novel potential agents to be integrated in salvage ALL therapy to further improve rescue outcome...
January 12, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28087255/unknown-face-of-known-drugs-what-else-can-we-expect-from-angiotensin-converting-enzyme-inhibitors
#14
REVIEW
Anna Wzgarda, Robert Kleszcz, Monika Prokop, Katarzyna Regulska, Milosz Regulski, Jaroslaw Paluszczak, Beata J Stanisz
The renin-angiotensin system (RAS) is one of important systems among homeostatic mechanisms that controls the function of cardiovascular, renal and adrenal systems. As RAS has a very complex nature, it has been also found as related to the control of cell migration and apoptosis. Angiotensin-converting enzyme inhibitors (ACEI) are drugs most commonly used in the modulation of RAS activity. ACEI have been extensively described as effective in the treatment of hypertension among adults, but also as drugs delaying progression in diabetic nephropathy and reducing mortality in left ventricular dysfunction and congestive heart failure...
January 10, 2017: European Journal of Pharmacology
https://www.readbyqxmd.com/read/28081320/pityriasis-rosea-a-natural-history-of-pediatric-cases-in-thecentral-anatolia-region-of-turkey
#15
Emine Çölgeçen, Çiğdem Kader, Yılmaz Ulaş, Pınar Öztürk, Öznur Küçük, Mehmet Balcı
BACKGROUND/AIM: This study aimed to evaluate the demographic, clinical, and epidemiological features of pityriasis rosea (PR) in a cohort of 46 children in Yozgat, a city in the Central Anatolia Region of Turkey. MATERIALS AND METHODS: Forty-six children with PR were monitored at regular intervals (1, 2, 4, and 12 weeks) for 3 months from the time of diagnosis. A complete evaluation of the patient was performed at each visit. RESULTS: The average age of patients at time of diagnosis was 12 ± 3...
December 20, 2016: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/28079914/intravenous-immunoglobulin-in-pediatric-rheumatology-when-to-use-it-and-what-is-the-evidence
#16
Martha M Rodriguez, Linda Wagner-Weiner
Intravenous immunoglobulin (IVIG) is given to children with a variety of rheumatologic illnesses. The mechanism of action by which it exerts therapeutic effects is not well understood and likely differs in the medical conditions for which it is given. IVIG is approved by the US Food and Drug Administration and is the standard of care for Kawasaki disease, but most IVIG use in pediatric rheumatology is "off-label. " The literature supports the use of IVIG for juvenile dermatomyositis, although it is unclear whether its use should be limited to those children with more severe or refractory disease...
January 1, 2017: Pediatric Annals
https://www.readbyqxmd.com/read/28079601/infliximab-optimization-based-on-therapeutic-drug-monitoring-in-pediatric-ibd
#17
Tatyana Hofmekler, Madeline Bertha, Courtney McCracken, Benadette Martineau, Elizabeth McKinnon, Bess T Schoen, Barbara O McElhanon, Gayathri Tenjarla, Subra Kugathasan, Cary Sauer
BACKGROUND: Infliximab (IFX) is an effective treatment for the management of moderate to severe inflammatory bowel disease (IBD). Low serum IFX levels are associated with the development of antibodies to IFX (ATI) which subsequently associated with clinical relapse and increased morbidity. The purpose of this study is to examine the relationship between dose and interval to IFX level. Secondary goal is to evaluate the relationship between IFX level and ATI in a pediatric IBD population...
June 21, 2016: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28079262/pediatric-obesity-pharmacokinetic-alterations-and-effects-on-antimicrobial-dosing
#18
Stephanie Natale, John Bradley, William Huy Nguyen, Tri Tran, Pamela Ny, Kirsten La, Eva Vivian, Jennifer Le
BACKGROUND: Limited data exist for appropriate drug dosing in obese children. This comprehensive review summarizes pharmacokinetic alterations that occur with age and obesity, and these effects on antimicrobial dosing. A thorough comparison of different measures of body weight and specific antimicrobial agents, including cefazolin, cefepime, ceftazidime, daptomycin, doripenem, gentamicin, linezolid, meropenem, piperacill-tazobactam, tobramycin, vancomycin, and voriconazole, are presented...
January 12, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28078682/population-pharmacokinetics-of-intravenous-clonidine-for-sedation-during-pediatric-extracorporeal-membrane-oxygenation-ecmo-and-continuous-veno-venous-hemofiltration-cvvh
#19
Niina Kleiber, Ron A A Mathôt, Maurice J Ahsman, Enno D Wildschut, Dick Tibboel, Saskia N de Wildt
AIMS: Clonidine is used for sedation in the pediatric intensive care unit. Extracorporeal membrane oxygenation (ECMO) provides temporary support if respiratory and cardiac function is threatened. ECMO influences the pharmacokinetics of drugs. Clonidine during pediatric ECMO cannot be effectively titrated as PK data are lacking. The aim of this study is to describe clonidine PK in a particular ECMO system and propose dosing guidelines for children on this particular ECMO circuit. METHODS: All children below the age of 18 who received clonidine during ECMO were eligible...
January 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28078628/3d-printed-drugs-for-children-are-we-ready-yet
#20
REVIEW
Maren Preis, Heidi Öblom
The first medicine manufactured by three-dimensional (3D) printing was recently approved by the Food and Drug Administration (FDA). The advantages of printing as a manufacturing route enabling more flexibility regarding the dose, and enlarging individual treatment options, have been demonstrated. There is a particular need for flexible drug delivery solutions when it comes to children. Printing as a new pharmaceutical manufacturing technology brings manufacturing closer to the patient and can easily be adjusted to the required dosing scheme, offering more flexibility for treatments...
January 11, 2017: AAPS PharmSciTech
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