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Pediatric Drug Development

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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
#1
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/28097507/in-vitro-phase-i-and-phase-ii-drug-metabolism-in-the-liver-of-juvenile-and-adult-g%C3%A3-ttingen-minipigs
#2
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/28093933/acute-kidney-injury-in-idiopathic-nephrotic-syndrome-of-childhood-is-a-major-risk-factor-for-the-development-of-chronic-kidney-disease
#3
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
#4
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
#5
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/28079601/infliximab-optimization-based-on-therapeutic-drug-monitoring-in-pediatric-ibd
#6
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/28078552/pediatric-development-of-bosentan-facilitated-by-modeling-and-simulation
#7
Jochen Zisowsky, Martine Géhin, Andjela Kusic-Pajic, Andreas Krause, Maurice Beghetti, Jasper Dingemanse
BACKGROUND: Bosentan is approved for use in adult patients with pulmonary arterial hypertension. The primary aim of the pharmacokinetic modeling was the provision of a systematic guidance for study design and enhanced understanding of pharmacokinetics across the entire pediatric age range. METHODS: A physiologically based pharmacokinetic model was developed for the pediatric population; starting from an adult model, the effects of body weight, age, and maturation of relevant metabolizing enzymes were incorporated to extrapolate the pharmacokinetics to children...
January 11, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28074348/challenges-and-opportunities-in-the-development-of-hiv-medications-in-pediatric-patients
#8
Gueorgui Dubrocq, Natella Rakhmanina, B Ryan Phelps
Successful management of pediatric HIV disease requires high therapeutic efficacy and adherence, which can be achieved by providing affordable, easy to store, and palatable antiretrovirals. Current challenges in pediatric antiretroviral drug development include poor palatability, large pill size, limited oral liquid formulations, and few incentives for development by drug manufacturers as the number of children with HIV continues to decline due to successful worldwide preventive interventions and improved access to antiretrovirals...
January 10, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28052798/diagnosis-and-management-of-allergic-conjunctivitis-in-pediatric-patients
#9
William E Berger, David B Granet, Alan G Kabat
BACKGROUND: Allergic conjunctivitis (AC), although one of the most common ocular disorders in pediatric patients, is frequently overlooked, misdiagnosed, and undertreated in children. OBJECTIVE: To guide pediatric health care professionals in the optimal diagnosis and management of AC in pediatric patients. METHODS: To identify any existing best practice guidelines for the diagnosis and treatment of AC in pediatric patients, a review of the literature published between 2004 and January 2015 was conducted...
January 1, 2017: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/28044936/nano-delivery-in-pediatric-tumors-looking-back-moving-forward
#10
Marta Colletti, Virginia Di Paolo, Angela Galardi, Giuseppe Maria Milano, Angela Mastronuzzi, Franco Locatelli, Angela Di Giannatale
Recent advances in the treatment of pediatric tumors led to an improvement of survival in this population. As a result, many pediatric survivors experience long-term effects that impact their quality of life. Therefore, it is extremely important to identify new treatment approaches that may target the tumor minimizing the drug-related side effects. Over the past 10 years, remarkable advances in nanomedicine have provided several potential tools for cancer treatment. Recently, there has been a growing interest towards therapeutic nanocarriers in the pediatric field, since they represent a new strategy to enhance the drug efficacy and reduce the toxicity...
January 2, 2017: Anti-cancer Agents in Medicinal Chemistry
https://www.readbyqxmd.com/read/28043528/childhood-tuberculosis-in-qatar
#11
Jay P N Singh, Reem Mohammed, Thanveer Thayyullathil, Abdullatif Al-Khal, Zubaida Al-Suwaidi
Childhood tuberculosis (TB) has been long neglected but has gained attention in recent years. In 2012, the World Health Organization annual report included an estimate for childhood TB for the first time, and in the following year, the TB Alliance received a grant from UNITAID (International Drug Purchase Facility) to develop pediatric TB formulations. Qatar is a low-incidence country. In this observational study, laboratory-confirmed cases of TB were analyzed from 2013 to 2015 and included patients aged ⩽14years...
December 2016: International Journal of Mycobacteriology
https://www.readbyqxmd.com/read/28043487/the-difficulties-of-childhood-tuberculosis-diagnosis
#12
A M Djouahra, M Ifticene, D Yala, F Boulahbal
AIMS AND OBJECTIVES: The WHO estimate that 8.8millions new cases of tuberculosis occurred in 2010, (between 8.5 and 9.2millions) linked to 1.45millions death cases. The load of children tuberculosis is estimated at 10-15 per cent of the total load. In 2014 more than one million children have developed the disease. The children just as adults are exposed to contract and develop the multi resistant forms of the tuberculosis, constituting a major issue for the disease control. The children less than 5years of age are the most exposed to present the most serious and more often deadly forms of the illness...
December 2016: International Journal of Mycobacteriology
https://www.readbyqxmd.com/read/28035989/neuroblastoma-a-paradigm-for-big-data-science-in-pediatric-oncology
#13
REVIEW
Brittany M Salazar, Emily A Balczewski, Choong Yong Ung, Shizhen Zhu
Pediatric cancers rarely exhibit recurrent mutational events when compared to most adult cancers. This poses a challenge in understanding how cancers initiate, progress, and metastasize in early childhood. Also, due to limited detected driver mutations, it is difficult to benchmark key genes for drug development. In this review, we use neuroblastoma, a pediatric solid tumor of neural crest origin, as a paradigm for exploring "big data" applications in pediatric oncology. Computational strategies derived from big data science-network- and machine learning-based modeling and drug repositioning-hold the promise of shedding new light on the molecular mechanisms driving neuroblastoma pathogenesis and identifying potential therapeutics to combat this devastating disease...
December 27, 2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28034356/improving-cancer-care-for-children-in-the-developing-world-challenges-and-strategies
#14
Zakiya Al Lamki
Cancer is a global health problem particularly in developing countries where the burden of cancer is ever increasing and claiming the lives of about 100,000 children under the age of 15 years every year. Majority of these occur in the Low and Middle Income Countries (LMICs) where 90% of world children live. Contributing factors to this trend is the reduction of communicable diseases and emergence of new infections, improvement of nutrition and socio-economic conditions, industrialization and urbanization. However, due to its complexity, childhood cancer is given the least priority by the governments' funding...
December 30, 2016: Current Pediatric Reviews
https://www.readbyqxmd.com/read/28030535/development-of-a-limited-sampling-strategy-for-the-estimation-of-exposure-to-high-dose-etoposide-after-intravenous-infusion-in-pediatric-patients
#15
Dorota Danielak, Joanna Sobiak, Jacek Wachowiak, Franciszek Główka, Maria Chrzanowska
BACKGROUND: Etoposide (VP-16), a podophylotoxin derivative, is used in conditioning regimens prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in children with acute lymphoblastic leukemia (ALL). The aim of this study was to develop a limited sampling strategy (LSS) suitable for the prediction of exposure to VP-16 defined as area-under-time-concentration curve (AUC). METHODS: The study included 28 pediatric patients with ALL, who were administered a 4h infusion of 60 mg/kg VP-16...
December 20, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28027180/pediatric-sialadenosis-due-to-valproic-acid
#16
Hatice Derin, Serhan Derin, Pembe Oltulu, Orhan Özbek, Hüseyin Çaksen
Sialadenosis is a rare entity characterized by bilateral diffuse, painless swelling of the parotid glands. Its etiology is not clear; however, it may occur due to adverse effects of some drugs. To our knowledge, sialadenosis due to valproic acid has not been reported in the literature up to date in any child. In this article, the authors presented a child who developed sialadenosis due to valproic acid, and improved after stopping use of the drug.
December 23, 2016: Journal of Craniofacial Surgery
https://www.readbyqxmd.com/read/28025239/off-label-use-of-medical-devices-in-children
#17
(no author information available yet)
Despite widespread therapeutic needs, the majority of medical and surgical devices used in children do not have approval or clearance from the Food and Drug Administration (FDA) for use in pediatric populations. The clinical need for devices to diagnose and treat diseases or conditions occurring in children has led to the widespread and necessary practice in pediatric medicine and surgery of using approved devices for "off-label" or "physician-directed" applications that are not included in FDA-approved labeling...
January 2017: Pediatrics
https://www.readbyqxmd.com/read/28018466/a-young-child-of-anti-nmda-receptor-encephalitis-presenting-with-epilepsia-partialis-continua-the-first-pediatric-case-in-korea
#18
Eun-Hee Kim, Yeo Jin Kim, Tae-Sung Ko, Mi-Sun Yum, Jun Hwa Lee
Anti-N-methyl D-aspartate receptor (anti-NMDAR) encephalitis, recently recognized as a form of paraneoplastic encephalitis, is characterized by a prodromal phase of unspecific illness with fever that resembles a viral disease. The prodromal phase is followed by seizures, disturbed consciousness, psychiatric features, prominent abnormal movements, and autonomic imbalance. Here, we report a case of anti-NMDAR encephalitis with initial symptoms of epilepsia partialis continua in the absence of tumor. Briefly, a 3-year-old girl was admitted to the hospital due to right-sided, complex partial seizures without preceding febrile illness...
November 2016: Korean Journal of Pediatrics
https://www.readbyqxmd.com/read/28017579/seizures-caused-by-brain-tumors-in-children
#19
Iván Sánchez Fernández, Tobias Loddenkemper
PURPOSE: To review the epidemiology, clinical features, and treatment of seizures secondary to pediatric brain tumors. METHOD: Literature review. RESULTS: Pediatric brain tumors are the most common solid pediatric tumor and the most common cause of death in pediatric cancer. Seizures are one of the most common symptoms of pediatric brain tumors. Factors associated with increased risk of seizures include supratentorial location, gray matter involvement, low-grade, and certain histological features-especially dysembryoplastic neuroepithelial tumor, ganglioglioma, and oligodendroglioma...
December 7, 2016: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/28006928/sufentanil-and-midazolam-dosing-and-pharmacogenetic-factors-in-pediatric-analgosedation-and-withdrawal-syndrome
#20
K Hronová, P Pokorná, L Posch, O Slanař
Our aim was to describe the effect of dosing and genetic factors on sufentanil- and midazolam-induced analgosedation and withdrawal syndrome (WS) in pediatric population. Analgosedation and withdrawal syndrome development were monitored using COMFORT-neo/-B scores and SOS score. Length of therapy, dosing of sufentanil and midazolam were recorded. Genotypes of selected candidate polymorphisms in CYP3A5, COMT, ABCB1, OPRM1 and PXR were analysed. In the group of 30 neonates and 18 children, longer treatment duration with midazolam of 141 h (2 - 625) vs...
December 21, 2016: Physiological Research
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