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https://www.readbyqxmd.com/read/28535123/topical-otic-drugs-in-a-multi-purpose-manufacturing-facility-a-guide-on-determination-and-application-of-permitted-daily-exposure-pde
#1
Lisa Wiesner, Maarten Prause, Ester Lovsin Barle
Due to newly introduced EU GMP guideline for Medicinal Products for Human and Veterinary use (PIC/S, 2015), product specific PDE for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. EMA (2014) guidance on setting PDE limits so far focused on systemic administration routes such as IV, oral or inhalation. This manuscript wants to give guidance on setting PDE values for risk management purposes in multi-purpose facilities for Active Pharmaceutical Ingredients (APIs) applied as topical otic drugs to the outer ear canal...
May 23, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28535077/sticky-situations-cyanoacrylate-exposures-reported-to-a-poison-control-system
#2
Shaun D Carstairs, Cynthia Koh, Lily Qian, Mariam Qozi, Grant Seivard, F Lee Cantrell
INTRODUCTION: Cyanoacrylate (Super Glue(®)) exposures are commonly reported to poison control centers, but little has been published in the medical literature regarding these exposures. We sought to characterize cyanoacrylate exposures reported to a poison control system. METHODS: We performed a retrospective review of a poison system's database for all cases of single-substance human exposure to cyanoacrylate-containing products from 2005 to 2015. Data collected included age, gender, route of exposure, clinical effects, treatments recommended and medical outcome...
May 23, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28502255/a-moist-edge-environment-aids-the-regeneration-of-traumatic-tympanic-membrane-perforations
#3
Z C Lou, Z H Lou
OBJECTIVE: To review the history of moist therapy used to regenerate traumatic tympanic membrane perforations. STUDY DESIGN: Literature review. METHODS: The literature on topical agents used to treat traumatic tympanic membrane perforations was reviewed, and the advantages and disadvantages of moist therapy were analysed. RESULTS: A total of 76 studies were included in the analysis. Topical applications of certain agents (e...
May 15, 2017: Journal of Laryngology and Otology
https://www.readbyqxmd.com/read/28498272/paget-s-disease-of-the-temporal-bone-a-single-institution-contemporary-review-of-27-patients
#4
Nicholas L Deep, Jake G Besch-Stokes, John I Lane, Colin L W Driscoll, Matthew L Carlson
OBJECTIVES: To report a contemporary review from a single-institution series on Paget's disease of the temporal bone (PDTB). STUDY DESIGN: Retrospective chart review of patients evaluated from 1998 to 2016. SETTING: Quaternary referral center. PATIENTS: Patients with radiographically confirmed PDTB. MAIN OUTCOME MEASURES: Clinical, audiological, and radiological features and management strategies of PDTB...
May 11, 2017: Otology & Neurotology
https://www.readbyqxmd.com/read/28492243/identification-of-mouse-cochlear-progenitors-that-develop-hair-and-supporting-cells-in-the-organ-of-corti
#5
Jinshu Xu, Hiroo Ueno, Chelsea Y Xu, Binglai Chen, Irving L Weissman, Pin-Xian Xu
The adult mammalian cochlear sensory epithelium houses two major types of cells, mechanosensory hair cells and underlying supporting cells, and lacks regenerative capacity. Recent evidence indicates that a subset of supporting cells can spontaneously regenerate hair cells after ablation only within the first week postparturition. Here in vivo clonal analysis of mouse inner ear cells during development demonstrates clonal relationship between hair and supporting cells in sensory organs. We report the identification in mouse of a previously unknown population of multipotent stem/progenitor cells that are capable of not only contributing to the hair and supporting cells but also to other cell types, including glia, in cochlea undergoing development, maturation and repair in response to damage...
May 11, 2017: Nature Communications
https://www.readbyqxmd.com/read/28459451/generation-of-inner-ear-organoids-containing-functional-hair-cells-from-human-pluripotent-stem-cells
#6
Karl R Koehler, Jing Nie, Emma Longworth-Mills, Xiao-Ping Liu, Jiyoon Lee, Jeffrey R Holt, Eri Hashino
The derivation of human inner ear tissue from pluripotent stem cells would enable in vitro screening of drug candidates for the treatment of hearing and balance dysfunction and may provide a source of cells for cell-based therapies of the inner ear. Here we report a method for differentiating human pluripotent stem cells to inner ear organoids that harbor functional hair cells. Using a three-dimensional culture system, we modulate TGF, BMP, FGF, and WNT signaling to generate multiple otic-vesicle-like structures from a single stem-cell aggregate...
May 1, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28458386/carotid-vertebrobasilar-anastomoses-with-reference-to-their-segmental-property
#7
Katsunari Namba
The primitive carotid-vertebrobasilar anastomoses are primitive embryonic cerebral vessels that temporarily provide arterial supply from the internal carotid artery to the longitudinal neural artery, the future vertebrobasilar artery in the hindbrain. Four types known are the trigeminal, otic, hypoglossal, and proatlantal intersegmental arteries. The arteries are accompanied by their corresponding nerves and resemble an intersegmental pattern. These vessels exist in the very early period of cerebral arterial development and rapidly involute within a week...
May 1, 2017: Neurologia Medico-chirurgica
https://www.readbyqxmd.com/read/28414607/cardiac-arrest-in-an-american-cocker-spaniel-during-a-deep-ear-flush-procedure
#8
Alexandra Gould, Fernando L Garcia-Pereira, W Dunbar Gram
CASE DESCRIPTION A 14-year-old spayed female American Cocker Spaniel with bilateral otitis media and no evidence of cardiovascular instability was anesthetized to allow performance of a deep ear flush. CLINICAL FINDINGS Otoscopic examination of the left ear revealed evidence of chronic inflammation; the ear was flushed with sterile saline (0.9% NaCl) solution. Examination of the right ear revealed more severe chronic inflammation than in the left ear, including a ruptured tympanum (timing of rupture unknown)...
May 1, 2017: Journal of the American Veterinary Medical Association
https://www.readbyqxmd.com/read/28393066/signaling-and-transcription-factors-during-inner-ear-development-the-generation-of-hair-cells-and-otic-neurons
#9
Héctor Gálvez, Gina Abelló, Fernando Giraldez
Integration between cell signals and bHLH transcription factors plays a prominent role during the development of hair cells of the inner ear. Hair cells are the sensory receptors of the inner ear, responsible for the mechano-transduction of sound waves into electrical signals. They derive from multipotent progenitors that reside in the otic placode. Progenitor commitment is the result of cell signaling from the surrounding tissues that result in the restricted expression of SoxB1 transcription factors, Sox2 and Sox3...
2017: Frontiers in Cell and Developmental Biology
https://www.readbyqxmd.com/read/28385905/in-vivo-characterization-of-an-ahr-dependent-long-non-coding-rna-required-for-proper-sox9b-expression
#10
Gloria R Garcia, Britton C Goodale, Michelle W Wiley, Jane K La Du, David A Hendrix, Robert L Tanguay
Xenobiotic activation of the aryl hydrocarbon receptor (AHR) by 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) prevents the proper formation of craniofacial cartilage and the heart in developing zebrafish. Downstream molecular targets responsible for AHR-dependent adverse effects remain largely unknown; however, in zebrafish sox9b has been identified as one of the most reduced transcripts in several target organs and is hypothesized to have a causal role in TCDD-induced toxicity. The reduction of sox9b expression in TCDD-exposed zebrafish embryos has been shown to contribute to heart and jaw malformation phenotypes...
April 6, 2017: Molecular Pharmacology
https://www.readbyqxmd.com/read/28361311/directed-differentiation-of-mouse-embryonic-stem-cells-into-inner-ear-sensory-epithelia-in-3d-culture
#11
Jing Nie, Karl R Koehler, Eri Hashino
The inner ear sensory epithelium harbors mechanosensory hair cells responsible for detecting sound and maintaining balance. This protocol describes a three-dimensional (3D) culture system that efficiently generates inner ear sensory epithelia from aggregates of mouse embryonic stem (mES) cells. By mimicking the activations and repressions of key signaling pathways during in vivo inner ear development, mES cell aggregates are sequentially treated with recombinant proteins and small molecule inhibitors for activating or inhibiting the Bmp, TGFβ, Fgf, and Wnt signaling pathways...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28353620/electrode-array-displacement-into-the-fallopian-canal-in-revisions-of-long-standing-cochlear-implants
#12
Jennifer Alyono, Garrett Locketz, Carleton Eduardo Corrales, Nikolas H Blevins
OBJECTIVE: To describe extracochlear extension of revision cochlear implant arrays into the Fallopian canal. PATIENTS: Two adult patients with extension of revision cochlear implant arrays into the Fallopian canal. INTERVENTIONS: Computed tomography (CT), selective deactivation of non-functional electrodes. MAIN OUTCOME MEASURES: Facial nerve function, facial nerve stimulation, cochlear implant electrode position, radiography, functional hearing...
June 2017: Otology & Neurotology
https://www.readbyqxmd.com/read/28330922/joint-histology-in-alligator-mississippiensis-challenges-the-identification-of-synovial-joints-in-fossil-archosaurs-and-inferences-of-cranial-kinesis
#13
Alida M Bailleul, Casey M Holliday
Archosaurs, like all vertebrates, have different types of joints that allow or restrict cranial kinesis, such as synovial joints and fibrous joints. In general, synovial joints are more kinetic than fibrous joints, because the former possess a fluid-filled cavity and articular cartilage that facilitate movement. Even though there is a considerable lack of data on the microstructure and the structure-function relationships in the joints of extant archosaurs, many functional inferences of cranial kinesis in fossil archosaurs have hinged on the assumption that elongated condylar joints are (i) synovial and/or (ii) kinetic...
March 29, 2017: Proceedings. Biological Sciences
https://www.readbyqxmd.com/read/28316289/post-stapedectomy-granuloma-a-devastating-complication
#14
E Watts, H R F Powell, S R Saeed, R M Irving
OBJECTIVES: This paper reports three cases of severe post-stapedectomy granuloma, emphasising the variable presentation of this devastating complication and the challenges of its management. METHODS: A retrospective review was conducted of three cases of post-stapedectomy granuloma requiring surgical debulking between 2010 and 2015. Clinical symptoms, serial imaging, histopathology and post-operative outcomes were considered. RESULTS: Intra-operatively, extensive granulation tissue with erosion of the otic capsule was found...
June 2017: Journal of Laryngology and Otology
https://www.readbyqxmd.com/read/28295766/impact-of-a-terbinafine-florfenicol-betamethasone-acetate-otic-gel-on-the-quality-of-life-of-dogs-with-acute-otitis-externa-and-their-owners
#15
Chiara Noli, Roberta Sartori, Tiziana Cena
BACKGROUND: Treatment of canine otitis externa with owner-administered products can be difficult. OBJECTIVES: To evaluate otic treatment administered by a veterinarian on quality of life (QoL) of dogs with otitis externa and their owners, and on clinical and cytology parameters of otitis; compared to an owner-administered treatment. ANIMALS: Fifty client-owned dogs randomly randomized into two groups and treated for 2 weeks. METHODS: Veterinarians treated Group A dogs with a veterinary licensed otic gel on two occasions at a 1 week interval; owners treated Group B dogs once daily with a veterinary licensed otic drop based product along with twice weekly cleaning...
March 15, 2017: Veterinary Dermatology
https://www.readbyqxmd.com/read/28287244/functional-differences-between-tcf1-isoforms-in-early-xenopus-development
#16
Giulietta Roël, Olaf Van Den Broek, Olivier Destrée
In Xenopus gastrula stage embryos, four isoforms of Tcf1 (B, C, D and E) are present with high amino acid sequence conservation compared to fish, mice and human. We studied possible functional differences between these Tcf1 isoforms during early Xenopus development. After overexpression of single Tcf1 isoforms, two distinct phenotypes were observed. Overexpression of the B or D isoforms of Tcf1, which both lack a C-clamp, enhances early canonical Wnt signaling and induces ectopic dorsal mesoderm at the expense of ventrolateral mesoderm prior to gastrulation, causing severe antero-dorzalization of embryos...
2017: International Journal of Developmental Biology
https://www.readbyqxmd.com/read/28264836/a-systems-level-approach-reveals-new-gene-regulatory-modules-in-the-developing-ear
#17
Jingchen Chen, Monica Tambalo, Meyer Barembaum, Ramya Ranganathan, Marcos Simões-Costa, Marianne E Bronner, Andrea Streit
The inner ear is a complex vertebrate sense organ, yet it arises from a simple epithelium, the otic placode. Specification towards otic fate requires diverse signals and transcriptional inputs that act sequentially and/or in parallel. Using the chick embryo, we uncover novel genes in the gene regulatory network underlying otic commitment and reveal dynamic changes in gene expression. Functional analysis of selected transcription factors reveals the genetic hierarchy underlying the transition from progenitor to committed precursor, integrating known and novel molecular players...
April 15, 2017: Development
https://www.readbyqxmd.com/read/28251698/use-of-oral-fluralaner-for-the-treatment-of-psoroptes-cuniculi-in-15-naturally-infested-rabbits
#18
Galia Sheinberg, Camilo Romero, Rafael Heredia, Miguel Capulin, Enrique Yarto, Juan Carpio
BACKGROUND: Psoroptes cuniculi, a nonburrowing ear mite, is a common ectoparasite of rabbits. Constant irritation of the auditory canal by the presence of this mite can lead to otitis externa or otoacariasis. OBJECTIVE: The goal of this study was to evaluate the effect of fluralaner on rabbits naturally infested with P. cuniculi and exhibiting clinical signs. ANIMALS: Fifteen female New Zealand domestic rabbits with otitis due to naturally occurring infestation with P...
March 1, 2017: Veterinary Dermatology
https://www.readbyqxmd.com/read/28248973/a-new-genus-and-species-of-marine-catfishes-siluriformes-ariidae-from-the-upper-eocene-birket-qarun-formation-wadi-el-hitan-egypt
#19
Sanaa E El-Sayed, Mahmoud A Kora, Hesham M Sallam, Kerin M Claeson, Erik R Seiffert, Mohammed S Antar
Wadi El-Hitan, the UNESCO World Heritage Site, of the Fayum Depression in the northeast part of the Western Desert of Egypt, has produced a remarkable collection of Eocene vertebrates, in particular the fossil whales from which it derives its name. Here we describe a new genus and species of marine catfishes (Siluriformes; Ariidae), Qarmoutus hitanensis, from the base of the upper Eocene Birket Qarun Formation, based on a partial neurocranium including the complete left side, partial right dentary, left suspensorium, two opercles, left pectoral girdle and spine, nuchal plates, first and second dorsal spines, Weberian apparatus and a disassociated series of abdominal vertebrae...
2017: PloS One
https://www.readbyqxmd.com/read/28218014/bilateral-otoneurological-pathology-to-operate-or-not
#20
Shivun Khosla, Matthew Elliot, Neil Donnelly
OBJECTIVE: To illustrate our experience when managing a complex patient with potentially life-threatening bilateral otological disease facing multisensory compromise including complete loss of audiovestibular function and visual disturbance Clinical presentation: A 67 year old lady, presented with a large left vestibular schwannoma and extensive right cholesteatoma encircling the otic capsule. She underwent translabyrinthine resection of the vestibular schwannoma, resulting in profound sensorineural hearing loss, vestibular hypofunction and corneal scarring following an initial temporary facial palsy...
March 2017: Cochlear Implants International
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