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Pediatric Drug Development

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https://www.readbyqxmd.com/read/27925849/development-and-prospective-federal-state-wide-evaluation-of-a-device-for-height-based-dose-recommendations-in-prehospital-pediatric-emergencies-a-simple-tool-to-prevent-most-severe-drug-errors
#1
Jost Kaufmann, Bernhard Roth, Thomas Engelhardt, Alex Lechleuthner, Michael Laschat, Christoph Hadamitzky, Frank Wappler, Martin Hellmich
OBJECTIVE: Drug dosing errors pose a particular threat to children in prehospital emergency care. With the Pediatric emergency ruler (PaedER), we developed a simple height-based dose recommendation system and evaluated its effectiveness in a pre-post interventional trial as the Ethics Committee disapproved randomization due to the expected positive effect of the PaedER on outcome. METHODS: Pre-interventional data were retrospectively retrieved from the electronic records and medical protocols of the Cologne Emergency Medical Service over a two-year period prior to the introduction of the PaedER...
December 7, 2016: Prehospital Emergency Care
https://www.readbyqxmd.com/read/27921260/development-of-oral-flexible-tablet-oft-formulation-for-pediatric-and-geriatric-patients-a-novel-age-appropriate-formulation-platform
#2
Prabagaran Chandrasekaran, Ruckmani Kandasamy
Development of palatable formulations for pediatric and geriatric patients involves various challenges. However, an innovative development with beneficial characteristics of marketed formulations in a single formulation platform was attempted. The goal of this research was to develop solid oral flexible tablets (OFTs) as a platform for pediatrics and geriatrics as oral delivery is the most convenient and widely used mode of drug administration. For this purpose, a flexible tablet formulation using cetirizine hydrochloride as model stability labile class 1 and 3 drug as per the Biopharmaceutical Classification System was developed...
December 5, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/27920397/optimizing-combination-therapy-for-acute-lymphoblastic-leukemia-using-a-phenotypic-personalized-medicine-digital-health-platform-retrospective-optimization-individualizes-patient-regimens-to-maximize-efficacy-and-safety
#3
Dong-Keun Lee, Vivian Y Chang, Theodore Kee, Chih-Ming Ho, Dean Ho
Acute lymphoblastic leukemia (ALL) is a blood cancer that is characterized by the overproduction of lymphoblasts in the bone marrow. Treatment for pediatric ALL typically uses combination chemotherapy in phases, including a prolonged maintenance phase with oral methotrexate and 6-mercaptopurine, which often requires dose adjustment to balance side effects and efficacy. However, a major challenge confronting combination therapy for virtually every disease indication is the inability to pinpoint drug doses that are optimized for each patient, and the ability to adaptively and continuously optimize these doses to address comorbidities and other patient-specific physiological changes...
December 5, 2016: Journal of Laboratory Automation
https://www.readbyqxmd.com/read/27920229/octreotide-use-in-post-cardiac-surgery-chylothorax-a-12-year-perspective
#4
Abdulrazaq Sheikh Aljazairi, Tauhid Ahmed Bhuiyan, Abdullah Hasan Alwadai, Rayd Abdulaziz Almehizia
BACKGROUND: Chylothorax following cardiothoracic surgery is a rare condition in pediatric patients with significant morbidity and mortality. Pharmacological management with octreotide suggests possible efficacy; however, current evidence is inadequate. The objective of this study was to assess the safety and efficacy of octreotide as a therapeutic option in this clinical setting. METHODS: This was a 12-year single-center retrospective cohort study of all patients (birth to 18-years old) who received octreotide for management of post-cardiac surgery chylothorax between January 2003 to August 2015...
December 5, 2016: Asian Cardiovascular & Thoracic Annals
https://www.readbyqxmd.com/read/27919878/pharmacy-residency-training-measured-through-a-standardized-knowledge-test
#5
Amy N Thompson, Brian P McKinzie, Jason S Haney, Jean M Nappi, Nicole Pilch
PURPOSE: The use of a standardized knowledge test to assess postgraduate year 1 (PGY1) pharmacy residency training was evaluated. METHODS: This was a retrospective review of a prospectively administered exam. A bank of questions was developed by preceptors from each of the core rotation disciplines: general medicine (including ambulatory care and oncology), pediatrics, critical care (including transplantation), drug information, operations, practice management, and psychiatry...
December 15, 2016: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/27909943/simulating-different-dosing-scenarios-for-a-child-appropriate-valproate-er-formulation-in-a-new-pediatric-two-stage-dissolution-model
#6
Frank Karkossa, Antonia Krueger, Jana Urbaniak, Sandra Klein
Predictive in vitro test methods addressing the parameters relevant to drug release in the pediatric gastrointestinal tract could be an appropriate means for reducing the number of in vivo studies in children. However, dissolution models addressing the particular features of pediatric gastrointestinal physiology and typical pediatric dosing scenarios have not yet been described. The objective of the present study was to combine the knowledge on common vehicle types and properties and current information on pediatric gastrointestinal physiology to design a dissolution model that enables a biorelevant simulation of the gastrointestinal conditions in young children...
December 1, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/27900937/post-authorization-changes-in-the-safety-and-efficacy-assessment-recommended-indications-and-drug-quality-profile-of-adalimumab-a-chronological-overview
#7
Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
November 30, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27900832/bromodomain-and-extraterminal-protein-inhibitors-in-pediatrics-a-review-of-the-literature
#8
REVIEW
Irene Jiménez, André Baruchel, François Doz, Johannes Schulte
The last few years have seen the identification of pharmacologic approaches to target bromodomain and extraterminal (BET) proteins for cancer treatment. These proteins have an essential role in gene transcription regulation by binding acetylated lysine residues on histone tails, activating gene transcription. BET inhibitors have been tested in preclinical models including pediatric malignancies and several adult clinical trials are ongoing. Since the development of new drugs in pediatric cancer has long lagged behind programs for adults, the aim of this review is to show the importance of these therapies in pediatric malignancies to support their development in pediatric oncology/hematology...
November 30, 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27894912/hearing-thresholds-at-high-frequency-in-patients-with-cystic-fibrosis-a-systematic-review
#9
Debora T M Caumo, Lúcia B Geyer, Adriana R Teixeira, Sérgio S M Barreto
INTRODUCTION: High-frequency audiometry may contribute to the early detection of hearing loss caused by ototoxic medications. Many ototoxic drugs are widely used in the treatment of patients with cystic fibrosis. Early detection of hearing loss should allow known harmful drugs to be identified before the damage affects speech frequencies. The damage caused by ototoxicity is irreversible, resulting in important social and psychological consequences. In children, hearing loss, even when restricted to high frequencies, can affect the development of language...
November 9, 2016: Brazilian Journal of Otorhinolaryngology
https://www.readbyqxmd.com/read/27889662/pediatric-pineal-germinomas-epigenetic-and-genomic-approach
#10
Monserrat Pérez-Ramírez, Alejo Justino Hernández-Jiménez, Armando Guerrero-Guerrero, Alicia Georgina Siordia-Reyes, Marta Elena Hernández-Caballero, Antonio García-Méndez, Fernando Chico-Ponce de León, Fabio Abdel Salamanca-Gómez, Normand García-Hernández
OBJECTIVE: We identify and correlate chromosomal alterations, methylation patterns and gene expression in pediatric pineal germinomas. METHODS: CGH microarray, methylation and gene expression were performed through the Agilent platform. The results were analyzed with MatLab software, MapViewer, DAVID, GeneCards and Hippie. RESULTS: Amplifications were found in 1q24.2, 1q31.3, 2p11.2, 3p22.2, 7p13, 7p15.2, 8p22, 12p13.2, 14q24.3 y 22q12; and deletions were found in 1q21...
November 19, 2016: Clinical Neurology and Neurosurgery
https://www.readbyqxmd.com/read/27884013/guidelines-for-growth-hormone-and-insulin-like-growth-factor-i-treatment-in-children-and-adolescents-growth-hormone-deficiency-idiopathic-short-stature-and-primary-insulin-like-growth-factor-i-deficiency
#11
Adda Grimberg, Sara A DiVall, Constantin Polychronakos, David B Allen, Laurie E Cohen, Jose Bernardo Quintos, Wilma C Rossi, Chris Feudtner, Mohammad Hassan Murad
BACKGROUND/AIMS: On behalf of the Drug and Therapeutics, and Ethics Committees of the Pediatric Endocrine Society, we sought to update the guidelines published in 2003 on the use of growth hormone (GH). Because idiopathic short stature (ISS) remains a controversial indication, and diagnostic challenges often blur the distinction between ISS, GH deficiency (GHD), and primary IGF-I deficiency (PIGFD), we focused on these three diagnoses, thereby adding recombinant IGF-I therapy to the GH guidelines for the first time...
November 25, 2016: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/27882736/crystalline-nephropathy-caused-by-tosufloxacin
#12
Risa Matsubara, Tetsuya Kibe, Takemasa Nomura
A 14-year-old girl was treated for 3 days with tosufloxacin (450 mg twice a day) for acute bronchitis and then developed acute kidney injury. Renal ultrasound showed enlarged kidneys without hydronephrosis. Urinalysis indicated drug crystal casts (2-3/HPF), consistent with drug-induced crystalline nephropathy. The patient recovered gradually with i.v. hydration and discontinuation of tosufloxacin, leading to the diagnosis of tosufloxacin crystalline nephropathy. Medical practitioners should be aware that crystalline nephropathy can occur in pediatric patients receiving tosufloxacin...
November 2016: Pediatrics International: Official Journal of the Japan Pediatric Society
https://www.readbyqxmd.com/read/27875026/disseminated-bcg-pneumonitis-revealing-severe-combined-immunodeficiencyxs-in-charge-syndrome
#13
Hyung Young Kim, Yoo-Mi Kim, Hee Ju Park
CHARGE (coloboma, heart defect, atresia choanae, retarded growth and development, genital hypoplasia, and ear anomalies/deafness) syndrome is a rare genetic disorder caused by CHD7 mutation and is related to immunodeficiency. A 6-month-old girl with right lung agenesis, congenital heart defects, and ear anomalies developed repeated and serious respiratory infection for a short period. She was clinically diagnosed with typical CHARGE syndrome with severe combined immunodeficiency (T-, B+, NK-); however, CHD7 mutation was not detected...
November 22, 2016: Pediatric Pulmonology
https://www.readbyqxmd.com/read/27871516/pediatric-patients-on-ketogenic-diet-undergoing-general-anesthesia-a-medical-record-review
#14
Elif Soysal, Heike Gries, Carter Wray
STUDY OBJECTIVE: To identify guidelines for anesthesia management and determine whether general anesthesia is safe for pediatric patients on ketogenic diet (KD). DESIGN: Retrospective medical record review. SETTING: Postoperative recovery area. PATIENTS: All pediatric patients who underwent general anesthesia while on KD between 2009 and 2014 were reviewed. We identified 24 patients who underwent a total of 33 procedures...
December 2016: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/27863623/tuberculous-lymphadenitis-of-the-head-and-neck-in-canadian-children-experience-from-a-low-burden-region
#15
Jason J Xu, Shazia Peer, Blake C Papsin, Ian Kitai, Evan J Propst
BACKGROUND: Children are more likely than adults to develop extra-pulmonary tuberculosis (EPTB), which often presents as cervical lymphadenopathy. The role of surgery in management is uncertain. We reviewed all head and neck EPTB cases presenting to our tertiary care pediatric institution over a twelve-year period. METHODS: All children 18 years of age and younger with EPTB involving the head and neck were included. We recorded clinical data and age at diagnosis, birth country, BCG vaccination status, as well as radiographic, surgical, histological, and microbiological results...
December 2016: International Journal of Pediatric Otorhinolaryngology
https://www.readbyqxmd.com/read/27857784/pyridoxine-dependent-convulsions-among-children-with-refractory-seizures-a-3-year-follow-up-study
#16
Sadanandavalli Retnaswami Chandra, Thomas Gregor Issac, Sai Deepak, Ravi Teja, Seby Kuruthukulangara
INTRODUCTION: Epilepsy accounts for 1% of the global disease burden and about 8-10 million epilepsy patients live in India. About 30-40% of these patients become drug-resistant and land up with palliative or disease-modifying surgeries. This is a situation causing great concern in view of the psychosocial and economic burden on the patient and the family apart from severe cognitive and motor consequences, especially in children. Therefore, it is mandatory to have an insight into the wide spectrum of causes with reference to refractoriness to antiepileptic medications in children with epilepsy...
July 2016: Journal of Pediatric Neurosciences
https://www.readbyqxmd.com/read/27856333/novel-homozygous-missense-mutation-in-aldh7a1-causes-neonatal-pyridoxine-dependent-epilepsy
#17
Emanuele G Coci, Luca Codutti, Christian Fink, Sophie Bartsch, Gunnar Grüning, Thomas Lücke, Ingo Kurth, Joachim Riedel
Pyridoxine dependent epilepsy (PDE) (OMIM#266100) is a neonatal form of epilepsy, caused by dysfunction of the enzyme α-aminoadipic semialdehyde dehydrogenase (ALDH7A1 or Antiquitin). This enzyme converts α-aminoadipic semialdehyde (α-AASA) into α-aminoadipate (AAA), a critical step in the lysine metabolism of the brain. ALDH7A1 dysfunction causes an accumulation of α-AASA and δ(1)-piperideine-6-carboxylic acid (P6C), which are in equilibrium with each other. P6C binds and inactivates pyridoxal 5'-phosphate (PLP), the active form of pyridoxine...
November 14, 2016: Molecular and Cellular Probes
https://www.readbyqxmd.com/read/27855965/prescribing-practices-for-systemic-agents-in-the-treatment-of-severe-pediatric-atopic-dermatitis-in-the-us-and-canada-the-pedra-treat-survey
#18
Christine R Totri, Lawrence F Eichenfield, Kirsty Logan, Laura Proudfoot, Jochen Schmitt, Irene Lara-Corrales, Jeffrey Sugarman, Wynnis Tom, Elaine Siegfried, Kelly Cordoro, Amy S Paller, Carsten Flohr
BACKGROUND: There is a paucity of literature to direct physicians in the prescribing of immunomodulators for patients with severe atopic dermatitis (AD). OBJECTIVE: To survey systemic agent prescribing practices for severe childhood AD among clinicians in the United States and Canada. METHODS: The TREatment of severe Atopic dermatitis in children Taskforce (TREAT), US&CANADA, a project of the Pediatric Dermatology Research Alliance (PeDRA), developed an online multiple-response survey to assess clinical practice, gather demographic information and details of systemic agent selection, and identify barriers to their use in patients with recalcitrant pediatric AD...
November 14, 2016: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/27855134/effects-of-ugt1a6-and-gabra1-on-standardized-valproic-acid-plasma-concentrations-and-treatment-effect-in-children-with-epilepsy-in-china
#19
Weixing Feng, Shenghui Mei, Leting Zhu, Yazhen Yu, Weili Yang, Baoqin Gao, Xiaojuan Wu, Zhigang Zhao, Fang Fang
BACKGROUND: Valproic acid (VPA) is a widely used antiepileptic drug with acceptable safety and efficacy in treating pediatric patients with various kinds of seizures. However, interindividual variations in plasma concentrations and treatment effects of patients with epilepsy treated with VPA are observed. This study aimed to evaluate the effects of various genetic variations on normalized plasma concentration of VPA (NCVPA) and the treatment response in Chinese children with epilepsy administered with VPA...
December 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27855053/-effect-of-immune-therapy-in-the-prognosis-of-viral-myocarditis-in-pediatric-patients
#20
Horacio Márquez-González, Diana López-Gallegos, Alicia María Dolores González-Espinosa, Jonathan Omar Zamudio-López, Lucelli Yáñez-Gutiérrez
BACKGROUND: Myocarditis is the inflammation of the myocardial tissue, primarily caused by viral infection. Dilated cardiomyopathy (MD) is the most serious complication. Immunomodulatory therapy is not validated in these patients; however, it appears to offer benefits in the prognosis of this disease. The aim of this work was to determine the prognosis of immunomodulatory therapy in the development of MD in pediatric patients with viral myocarditis effect. METHODS: A retrospective cohort of patients between 4 and 17 years diagnosed with viral myocarditis was integrated...
2016: Revista Médica del Instituto Mexicano del Seguro Social
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