Here is your PDF: Microsoft Word – Refl Paper Formulations of choice FINAL to CHMP; Keywords: 2006 paediatric working party 2005 medicines human

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2019-02-07 23:00:24.024863

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European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use 7 Westferry Circus, Canar y Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 70 40 E-mail: mail@emea.europa.eu www.emea.europa.eu EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 28 July 2006 EMEA/CHMP/PEG/194810/2005 COMMITTEE FOR MEDICINAL PR ODUCTS FOR HUMAN USE (CHMP) REFLECTION PAPER: FORMULATIONS OF CHOICE FOR THE PAEDIATRIC POPULATION AGREED BY PAEDIATRIC WORKING PARTY & QUALITY WORKING PARTY May 2005 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 23 June 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) 31 December 2005 AGREED BY PAEDIATRIC WORKING PARTY 28 July 2006 ADOPTION BY CHMP 21 September 2006

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Here is your PDF: Microsoft Word – Drugabs.doc; Keywords: drug drugs > administration certain into this

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CCNMTL

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2019-02-07 23:00:31.417844

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19DRUG ABSORPTION, DISTRIBUTION AND ELIMINATION; PHARMACOKINETICS I. DRUG ADMINISTRATION Often the goal is to attain a therapeutic drug concentration in plasma from which drug enters the tissue (therapeutic window between toxic concentration and minimal effective concentration). A. Enteral Routes 1. Sublingual (buccal) Certain drugs are best given beneath the tongue or retained in the cheek pouch and are absorbed from these re gions into the local circulation. These vascular areas are ideal for lipid-soluble drugs that would be metabolized in the gut or liver, sin ce the blood vessels in the mouth bypass the liver (do not undergo first pass liv er metabolism), and drain directly into the systemic circulation. This r oute is usually reserved for nitrates and certain hormones. 2. Oral By far the most common route. The passage of drug from the gut into the blood is influenced by biologic and phys icochemical factors (discussed in detail below), and by the dosage form. For most drugs, two- to five-fold differences in the rate or extent of gastrointestinal ab sorption can occur, depending on the dosage form. These two characteristics, rate and completeness of absorption, comprise bioavailability . Generally, the bioavailability of oral drugs follows the order: solution > suspension > capsule > tablet > coated tablet. 3. Rectal The administration of suppositories is usually reserved for situations in which oral administration is difficult. This route is more frequently used in small children. The rectum is devoid of villi, thus absorption is often slow. B. Parenteral Routes 1. Intravenous injection Used when a rapid clinical response is necessary, e.g., an acute asthmatic episode. This route allows one to achieve relatively precise drug concentrations in the plasma, since bi oavailability is not a concern. Most drugs should be injected over 1-2 minutes in order to prevent the occurrence of very high drug concentra tions in the injected vein, possibly causing adverse effects. Some drugs , particularly those with narrow therapeutic indices or short half-lives, are best administered as a slow IV infusion or drip. 2. Intra-arterial injection Used in certain special situations, notably with anticancer drugs, in an effort to deliver a high concentrati on of drug to a particular tissue. Typically, the injected artery lead s directly to the target organ.

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Here is your PDF: QuickBooks 2016: The Missing Manual; Keywords: ebook bundle intuit customers save 40% printed

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Bonnie Biafore

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2019-02-09 17:28:15.536295

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Here is your PDF: NASA Technology Roadmaps TA 2: In-Space Propulsion Technologies; Keywords: nasa technology roadmaps ta 2: in-space propulsion

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2019-02-09 17:47:00.472478

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NASA Technology Roadmaps TA 2: In-Space Propulsion Technologies 2015

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Here is your PDF: Otsego County, NY Community Needs Assessment; Keywords: leader developing innovative solutions promote healthy lives,

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OFO

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2019-02-09 17:40:56.091713

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The leader in developing innovative solutions that promote healthy lives, thriving families, and caring communities. Otsego County Community Needs Assessment 2017

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Here is your PDF: Getting Started: A Guide for Creating School Gardens as Outdoor Classrooms; Keywords: school getting started guide creating gardens outdoor

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Life Lab Science Program / Center for Ecoliteracy

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2019-02-09 15:53:47.293054

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Getting Started A Guide for Creating School Gardens as Outdoor Classrooms Your school garden provides the context to learn aboutthe world we live in. Shaping and supporting the developing plant, tying the tendrils of the blue morning glories. © CEL/Barlow ®

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Here is your PDF: SIS FactFinder: Systemic Effects of Epidural Corticosteroid Injection; Keywords: systemic epidural corticosteroids used spine effects injections

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Spine Intervention Society

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2019-02-07 23:00:13.909156

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1 SPINE INTERVENTION SOCIETYSIS JUNE 1, 2017DOWNLOADED FROM SPINEINTERVENTION.ORG/FACTFINDERS ©2017 SPINE INTERVENTION SOCIETY. ALL RIGHTS RESERVED . Systemic Effects of Epidural Corticosteroid Injection Wade King, MMed; David C. Miller, MD, MA; and Clark Smith, MD, MPH on behalf of the Spine Intervention Society™s Patient Safety Committee Myth: Transforaminal and interlaminar epidural injections of corticosteroids can be administered without concern for systemic effects because the doses used are small and intermittent. Fact: The doses of corticosteroids administered in interventional spine procedures have systemic effects, especially when the patient has a steroid-dependent condition such as diabetes mellitus or has multiple exposures to steroids. Transforaminal and interlaminar epidural injections of corticosteroids are used to treat radicular pain. The epidural plexus of veins, and can exert systemic effects. The risk of side-effects is dependent on the dose used and the number of injections given over time. The nature of systemic effects depends on the systems affected and the duration of exposure to steroids. PharmacologyThe corticosteroids used in spinal pain management are glucocorticoids. They act by binding to glucocorticoid Glucocorticoids are metabolized in the liver to inactive glucuronides and sulfates, and are excreted mainly by the kidneys, but also in feces. The half-lives of glucocorticoids vary, but are of the order of several days. For example, the side-effects. DoseFor transforaminal injection of steroids (TFIS) dexamethasone has become the preferred agent, because it does not such as triamcinolone or betamethasone have been used in the past. For interlaminar epidural injections similar one nerve root is the target. There are no published data comparing the incidence, severity or duration of systemic Systemic Side-Effects Long-term systemic side-effects may arise if corticosteroids are administered on a continuing basis, or given repeatedly at intervals too short for the body to have cleared the previous dose(s). Long-term effects may be caused directly by excess glucocorticoid in the circulation or indirectly through suppression of the hypothalamic-pituitary

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Here is your PDF: Microsoft Word – School Grants Synthesis of Five Countries.docx; Keywords: school grants lead improvement? an overview experiences

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2019-02-09 15:29:29.893586

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Can school grants lead to school improvement? An overview of experiences of five countries Working paper

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Here is your PDF: Guidelines for the Oversight of Field/WildlifeStudies; Keywords: The UMD IACUC is responsible for the oversight of all research, testing and training activities involving live vertebrate animals, including those taking place at field sites (either local or remote) where the activity alters or influences (directly or indirectly) the activities of the animals being studied

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PAMELA LANFORD – University of Maryland College Park

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2019-02-08 22:26:32.640794

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Introduction The UMD IACUC is responsible for the oversight of all research, testing and training activities involving live vertebrate animals, including those taking place at field sites (either local or remote) where the activity alters or influences (directly or indirectly) the activities of the animals being studied. In the case of field studies, protocols must provide sufficient information such that the IACUC can evaluate the location and nature of the field site, impact on study animals, risks to other wildlife or to the surrounding environment, as well as occupational health of personnel involved in the study. Evaluation of activities in field/wildlife settings will be performed using appropriate professional societal guidelines (see below) and occupational health considerations should be, at a minimum, compliant with the UMD occupational health policy on field studies. Definitions Direct manipulation – Activities that involve the handling and/or physical restraint of animals by study personnel, including capture and release, netting, banding, and other activities that require handling of the animal by study personnel. Indirect manipulation – Activities that materially alter or influence the normal behavior activity the animals, without handling and/or physical restraint, such as restricting range or migration patterns (fencing). Observation Only – Activities that do not materially alter or influence the normal behavior of the animal(s) or the habitat, such as animal counts, photographic documentation, attracting via food source, playing audio recording of calls, or other activities that influence the behavior of the animal within the normal range of behaviors for that species. Field site – Location of wildlife study that is outside the UMD physical facilities (laboratory and/or agricultural buildings), typically in an area of agricultural or forest land, or some other undeveloped region. Standards Standards used for the evaluation of field study protocols include, but are not necessarily limited to, the follow professional society guidelines: • The Wildlife Techniques Manual (Wildlife Society) • Guidelines for the Use of Fishes in Research www.asih.org/sites/default/files/documents/publications/asf-guidelines-use-of-fishesin-research-2013.pdf (American Fisheries Society, 2013) • Guidelines for the Use of Live Amphibians and Reptiles in Field Research www.asih.org/sites/default/files/documents/resources/guidelinesherpsresearch2004.pdf (Herpetological Animal Care and Use Committee [HACC] of the American Society of Ichthyologists and Herpetologists, 2004) • Guidelines to the Use of Wild Birds in Research naturalhistory.si.edu/BIRDNET/documents/guidlines/Guidelines_August2010.pdf (The Ornithological Council, 2010) • Guidelines of the American Society of Mammalogists for the use of wild mammals in research www.mammalsociety.org/uploads/Sikes%20et%20al%202011.pdf (American Society of Mammalogists, 2011) Methodology – Protocol requirements Exempted Activities A full UMD IACUC protocol is not required if the field study activity does not directly or indirectly materially alter or influence the activity of the animals. Requirements of specific funding agencies may supersede this exemption. PIs seeking to have field studies assigned to exempt status must complete the abbreviated field studies form, to be submitted via the online protocol submission system. Field studies assigned exempt status may be subject to reevaluation by the IACUC for conditions including, but not limited to, changes in federal, state, local, or institutional policy or changes in funding source. Regardless of the requirement for an IACUC protocol, the investigator should be aware that she/he is responsible for the occupational health and safety of all personnel involved in the study, and for the assessment and communication of risks/hazards that may impact human health and safety. (See below, Post-Approval Monitoring and Occupational Health.) Non-exempted Activities A full protocol is required for all studies where the activities or behavior of animal(s) is/are altered or influenced (either directly or indirectly), and must address the specific concerns below, in addition to the non-field study information typically provided in the Animal Study Protocol. An additional section (Section I – Field Studies) should be included in the initial protocol submission. The following items should be consider when creating the field study protocol: Study Site Selection and Justification The study site for the research should maximize the opportunity for data collection and minimize the disruption caused by the investigator. The site selection process should also take into consideration other wildlife and activities in the area, such as agricultural practices, tourism, and hunting, which may interfere with the research protocol. Procedures involving site manipulation should be adequately justified by the investigator. If fences are erected to limit movement of individuals or populations, the impact on other species should be considered. Upon study completion, any erected structures must be removed and original habitat restored.

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Here is your PDF: untitled; Keywords: teaching guide: literacy phonicsliteracy phonicsnsw department education

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2019-02-09 15:39:18.443462

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PhonicsLiteracy teaching guide: PhonicsNSW Department of Education and Training Learning and Development The Literacy teaching guide: Phonics and the Literacy teaching guide: Phonemic awareness are companion guides and as such should be read in conjunction with each other.

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