Corticosteroids ELISA

Total Page:16

File Type:pdf, Size:1020Kb

Corticosteroids ELISA THE PRESENT DOCUMENT IS A FAC-SIMILE VERSION When performing the assay, please use the kit insert Enzyme immunoassay for the detection of tetracyclines (code AB754/AB752) B ZERO® Tetra/Epimers is an ELISA kit prepared for an immunoenzymatic assay for the quantitative analysis of tetracyclines. 1 TEST PRINCIPLE The kit contains the procedure and the materials sufficient for The assay is performed in plastic microwells that have been 96 determinations (code AB754) or 48 determinations (code coated with anti-tetracycline antibody. Assay buffer, AB752). tetracycline zero standard solution or samples and the enzyme A microtiter plate photometer or a strip photometer is conjugate are added to the microplate. During the first required. incubation, free tetracycline molecules eventually contained in the sample and the enzyme-labelled tetracycline compete for Analysable samples the anti-tetracycline antibody binding sites on the solid phase. Muscle, honey, milk, shrimp, water. Any unbound molecule is then removed from the solid phase in a washing step. The binding between the enzyme conjugate Sample preparation and the antibody is detected by a chromogenic substrate. The (Homogenization), mixing, (centrifugation), dilution. enzyme converts the colourless chromogen into a blue product. The addition of the stop reagent leads to a colour Assay time: 90 minutes (sample preparation not included). change from blue to yellow. The absorbance is measured by a microplate reader at 450 nm. The colour development is Detection limit (in tetracycline equivalents) inversely proportional to the tetracycline concentration in the Honey, milk, shrimp: 4 ppb sample. Muscle: 8 ppb Water: 1.11 ppb 2 PROVIDED REAGENTS Specificity Microtiter plate: coated with anti-tetracycline antibody. Analyte Cross-reactivity (%) As the strips are breakable, the wells can be used individually. Lotto: 02090P Rev.1 del 12-10-2010 tetracycline 100 For this purpose, it is sufficient to get out the wells from the frame and to break the joint. oxytetracycline 95 Assay buffer: 1 plastic vial. 4-epi-tertacycline 95 Std 0: 1 amber plastic bottle containing the standard 0 ng/ml of tetracycline. ATTENTION: only the standard zero is demeclocycline 90 provided. B/B0 values of calibration curve (0,1-0,8ng/ml) are rolitetracycline 80 reported in the kit certificate of conformity. Enzyme conjugate: 1 amber glass bottle containing chlortetracycline 80 lyophilized enzyme conjugate. Enzyme conjugate diluent: 1 amber plastic bottle. 4-epi-oxytetracycline 70 Sample diluent 10X: 1 plastic bottle. metacycline 60 Washing-buffer 5X: 1 plastic bottle. Developing solution: 1 amber plastic bottle. doxytetracycline 50 Stop solution: 1 plastic vial. 4-epi-chlortetracycline 30 _________________________________________________________ 1 Tecna S.r.l. – Società a socio unico - Area Science Park - Padriciano 99, Trieste, Italy V.3 - 01/19 tel: +39 040 3755341; fax +39 040 3755343 e-mail: [email protected] web: www.tecnalab.com Enzyme conjugate: After the vial has reached the room temperature, resuspend the lyophilized enzyme conjugate with 1 ml of enzyme diluent. Calculate and prepare the necessary Component Code AB754 – 96 det. Code AB752 – 48 det. quantity for the experiment. Dilute the conjugate 1/25 in the Microtiter plate 96 wells 48 wells enzyme diluent (for example: take 30 l of concentrated (12 strips x 8 wells) (6 strips x 8 wells) Assay buffer 6ml 6ml enzyme conjugate + 720 l of enzyme diluent). Std 0 4 ml 3 ml ATTENTION: do not take less than 20 l of concentrate Enzyme conjugate 2 vials 2 vials enzyme conjugate from the vial. Enzyme conjugate diluent 2x12 ml 2x12 ml Sample diluent 10x 2x25 ml 25 ml Enzyme conjugate diluent: ready to use; Washing buffer 5x 2x100ml 100 ml Sample diluent 10x: dilute the dilution buffer 1:10 (for Developing solution 16 ml 12 ml example: 1+9) with distilled water. Stop solution 12 ml 6 ml Washing buffer 5x: dilute the concentrated 1:5 with distilled water (for example 25 ml + 100 ml of distilled water). The diluted washing buffer is stable at room temperature for 3 MATERIALS REQUIRED BUT NOT PROVIDED 24 hours and at +2/+8°C for two weeks. - Distilled water Developing solution: ready to use. - Methanol (muscle) Stop solution: ready to use. - Methanol 80% (shrimp) McIlvaine buffer (only for muscle extraction): - McIlvain Buffer pH 7.0 (muscle) 1. Prepare a 0.2M sodium phosphate dibasic solution: 14.2g Equipment of Na2HPO4 to 500 ml of distilled water. - Balance 2. Prepare a 0.1M citric acid solution: 2.94 g of citric acid - For grinding: grinder or blender “Osterizer” like (muscle, trisodium salt to 100 ml of distilled water. shrimp) 3. Mix 164.7 ml of 0.2M Na2HPO4 solution with 35.3 ml of - For extraction: vortex (muscle, honey, shrimp), shaker 0.1M citric acid solution. (muscle, shrimp) 4. Adjust pH to 7.0 with NaOH or HCl if necessary. - Centrifuge for 15ml vials (muscle, shrimp, optional for honey) 7 SAMPLES PREPARATION - 0,2µm polysulfone filter (water) 7.1 Honey - 20-200 l micropipette with tips. - Dilute 0,5g of honey with 19,5 ml of sample diluent 1x. - 200-1000 l micropipette with tips. - Mix on vortex until complete dissolution (centrifugation - 500-300 l multichannel micropipette with tips. at 3000 g for 5 minutes will help with samples exhibiting - Microtiter plate or strip reader equipped with a 450 nm precipitates) filter. The dilution factor is 40. 7.2. Muscle 4 WARNING AND PRECAUTIONS FOR THE USERS - Finely grind the sample. - For in vitro diagnostic use only. - Prepare the sample extraction solution mixing 1 part - Some reagents contain solutions that may be identified as McIlvain Buffer and 1 part of methanol. dangerous substance by the Regulation (EC) No - Weigh 1 g of sample and add 3 ml of sample extraction 1272/2008. Please refer to Safety Data Sheet available on solution. Tecna web site. - Vortex thoroughly for 1 minute. - Handle the reagents with caution, avoiding contact with - Mix on shaker for 40 minutes. skin, eyes and mucous membranes. - Centrifuge at 2000 x g for 10 minutes - Dilute supernatant 20x with the sample diluent 1x (for 5 HANDLING AND STORAGE INSTRUCTIONS example: 50l of milk + 950l of buffer). - Store the kit at +2/+8 °C. The dilution factor is 80. - Enzyme conjugate provided is lyophilized. Once reconstituted, the concentrated enzyme conjugate 7.3. Milk solution will remain viable for 4 weeks (store at - - Dilute the sample 40x with the sample diluent 1x (for 20°C). example: 50l of milk + 1950l of buffer) - Reseal the unused strips of the anti-tetracycline microtiter The dilution factor is 40. plate in the bag together with the desiccant bag provided. - Do not use components after the expiration date. 7.4. Shrimp - Do not intermix components between different kit lots. - Finely grind the sample. - Weigh 1 g of sample and add 3 ml of methanol 80%. - Do not use photocopies of the instruction booklet. Follow always the instruction booklet that is included inside the - Vortex thoroughly for 1 minute. kit box. - Mix on shaker for 20 minutes. - Centrifuge at 2000 x g for 10 minutes. - Transfer 2 ml of supernatant in a clean vial. 6 WORKING SOLUTIONS PREPARATION - Centrifuge at 2000 x g for 10 minutes. Assay buffer: ready to use. - Dilute supernatant 10x with the sample diluent 1x (for Std 0: ready to use. example: 100l + 900l of buffer). _________________________________________________________ 2 Tecna S.r.l. – Società a socio unico - Area Science Park - Padriciano 99, Trieste, Italy tel: +39 040 3755341; fax +39 040 3755343 e-mail: [email protected] web: www.tecnalab.com The dilution factor is 40. - Remove the remaining droplets by tapping the 7.5. Water microplate upside down vigorously against - Filter the sample using a 0.2µm polysulfone filter. absorbent paper. - Prepare sample diluent 1x using the sample to dilute 10x Do not allow the wells to dry out. buffer (for example: 100l of sample diluent 10x + 900l 7. Using the multichannel micropipette, add 150 of sample). The dilution factor is 1.11. l of developing solution to each well and shake the plate gently with rotatory motion for 8 ASSAY PROCEDURE few seconds. 8.1 Preliminary comments 8. Incubate for 30 minutes at room temperature. - Bring all reagents to room temperature before use; keep 9. Using the multichannel micropipette, add 100 them at room temperature at least for one hour. - Store reagents at +2/+8°C immediately after use. l of stop solution to each well and mix Concentrated enzyme conjugate should be stored at - thoroughly with rotatory motion for few 20°C. seconds. - Do not change the assay procedure, in particular: 1. Measure the absorbance at 450 nm. Read - do not prolong the incubation time; within 15 minutes. - do not incubate the plate at temperatures higher than 25°C or lower than 18°C; - do not shake the plate during the incubations; 9 RESULTS CALCULATION - Divide the absorbance value of each sample by the - use for dispensing accurate and precise micropipettes absorbance of the standard 0 (B ) and multiply by 100; with suitable tips; 0 - once started, complete all the steps without the Maximum Binding (B0) is thus made equal to 100% interruption; and the absorbance values are quoted in percentage: - avoid to dry out the wells; - The reproducibility of the results depends largely upon Sample absorbance B --------------------------------------------- X 100 = ---- (%) the efficiency and uniformity of microwells washing; always keep to the described procedure. standard 0 (B0) absorbance B0 - Use a single disposable tip for each sample to avoid cross-contamination. - Enter the (%) B/B0 values provided in the kit lot - Do not allow tips to contact the liquid already in the conformity certificate for each standard (0.1; 0.2; 0.3; 0.4; microwells or the internal microwells surface. 0.6; 0.8 ng/ml) in a semi-logarithmic system of coordinates against the standard tetracycline - Avoid direct sunlight during all incubations and cover the microtiter plate without using sealing tapes.
Recommended publications
  • Pharmaceutical and Veterinary Compounds and Metabolites
    PHARMACEUTICAL AND VETERINARY COMPOUNDS AND METABOLITES High quality reference materials for analytical testing of pharmaceutical and veterinary compounds and metabolites. lgcstandards.com/drehrenstorfer [email protected] LGC Quality | ISO 17034 | ISO/IEC 17025 | ISO 9001 PHARMACEUTICAL AND VETERINARY COMPOUNDS AND METABOLITES What you need to know Pharmaceutical and veterinary medicines are essential for To facilitate the fair trade of food, and to ensure a consistent human and animal welfare, but their use can leave residues and evidence-based approach to consumer protection across in both the food chain and the environment. In a 2019 survey the globe, the Codex Alimentarius Commission (“Codex”) was of EU member states, the European Food Safety Authority established in 1963. Codex is a joint agency of the FAO (Food (EFSA) found that the number one food safety concern was and Agriculture Office of the United Nations) and the WHO the misuse of antibiotics, hormones and steroids in farm (World Health Organisation). It is responsible for producing animals. This is, in part, related to the issue of growing antibiotic and maintaining the Codex Alimentarius: a compendium of resistance in humans as a result of their potential overuse in standards, guidelines and codes of practice relating to food animals. This level of concern and increasing awareness of safety. The legal framework for the authorisation, distribution the risks associated with veterinary residues entering the food and control of Veterinary Medicinal Products (VMPs) varies chain has led to many regulatory bodies increasing surveillance from country to country, but certain common principles activities for pharmaceutical and veterinary residues in food and apply which are described in the Codex guidelines.
    [Show full text]
  • Treatment Processes for Microbial Resistance Mitigation: the Technological Contribution to Tackle the Problem of Antibiotic Resistance
    International Journal of Environmental Research and Public Health Review Treatment Processes for Microbial Resistance Mitigation: The Technological Contribution to Tackle the Problem of Antibiotic Resistance Gabriela Bairán 1, Georgette Rebollar-Pérez 2, Edith Chávez-Bravo 1,* and Eduardo Torres 1,* 1 Instituto de Ciencias, Benemérita Universidad Autónoma de Puebla, Puebla 72570, Mexico; [email protected] 2 Facultad de Ingeniería Química, Benemérita Universidad Autónoma de Puebla, Puebla 72570, Mexico; [email protected] * Correspondence: [email protected] (E.C.-B.); [email protected] (E.T.) Received: 24 September 2020; Accepted: 24 November 2020; Published: 28 November 2020 Abstract: Advances generated in medicine, science, and technology have contributed to a better quality of life in recent years; however, antimicrobial resistance has also benefited from these advances, creating various environmental and health problems. Several determinants may explain the problem of antimicrobial resistance, such as wastewater treatment plants that represent a powerful agent for the promotion of antibiotic-resistant bacteria (ARB) and antibiotic resistance genes (ARG), and are an important factor in mitigating the problem. This article focuses on reviewing current technologies for ARB and ARG removal treatments, which include disinfection, constructed wetlands, advanced oxidation processes (AOP), anaerobic, aerobic, or combined treatments, and nanomaterial-based treatments. Some of these technologies are highly intensive, such as AOP; however, other technologies require long treatment times or high doses of oxidizing agents. From this review, it can be concluded that treatment technologies must be significantly enhanced before the environmental and heath problems associated with antimicrobial resistance can be effectively solved.
    [Show full text]
  • ( 12 ) United States Patent ( 10 ) Patent No .: US 10,835,538 B2 Averback ( 45 ) Date of Patent : Nov
    US010835538B2 ( 12 ) United States Patent ( 10 ) Patent No .: US 10,835,538 B2 Averback ( 45 ) Date of Patent : Nov. 17 , 2020 ( 54 ) METHOD OF TREATING BENIGN 7,241,738 B2 7/2007 Averback et al . 7,317,077 B2 1/2008 Averback et al . PROSTATIC HYPERLASIA WITH 7,408,021 B2 8/2008 Averback et al . ANTIBIOTICS 7,745,572 B2 6/2010 Averback et al . 8,067,378 B2 11/2011 Averback et al . ( 71 ) Applicant: Nymox Corporation , Nassau ( BS ) 8,293,703 B2 10/2012 Averback et al . 8,569,446 B2 10/2013 Averback et al . 8,716,247 B2 5/2014 Averback et al . ( 72 ) Inventor : Paul Averback , Nassau ( BS ) 2016/0215031 Al 7/2016 Averback 2016/0361380 A1 12/2016 Averback ( 73 ) Assignee : NYMOX CORPORATION , Nassau 2017/0020957 Al 1/2017 Averback ( BS ) 2017/0360885 Al 12/2017 Averback 2018/0064785 Al 3/2018 Averback ( * ) Notice : Subject to any disclaimer , the term of this patent is extended or adjusted under 35 FOREIGN PATENT DOCUMENTS U.S.C. 154 ( b ) by 21 days. WO 90/08555 A1 8/1990 WO WO - 2007149312 A2 * 12/2007 A61K 8/606 ( 21 ) Appl. No .: 15 /938,920 ( 22 ) Filed : Mar. 28 , 2018 OTHER PUBLICATIONS McClellan et al. , Topical Metronidazole A Review of its Use in ( 65 ) Prior Publication Data Rosacea, 2000 , Am J Clin Dermatol, 1 ( 3 ) , pp . 191-199 ( Year: 2000 ) . * US 2019/0298731 A1 Oct. 3 , 2019 Ricciotti et al . , Prostaglandins and Inflammation, 2011 , Arterioscler Thromb Vasc Biol . , 31 ( 5 ) , pp . 986-1000 ( Year: 2011 ) . * ( 51 ) Int .
    [Show full text]
  • Customs Tariff - Schedule
    CUSTOMS TARIFF - SCHEDULE 99 - i Chapter 99 SPECIAL CLASSIFICATION PROVISIONS - COMMERCIAL Notes. 1. The provisions of this Chapter are not subject to the rule of specificity in General Interpretative Rule 3 (a). 2. Goods which may be classified under the provisions of Chapter 99, if also eligible for classification under the provisions of Chapter 98, shall be classified in Chapter 98. 3. Goods may be classified under a tariff item in this Chapter and be entitled to the Most-Favoured-Nation Tariff or a preferential tariff rate of customs duty under this Chapter that applies to those goods according to the tariff treatment applicable to their country of origin only after classification under a tariff item in Chapters 1 to 97 has been determined and the conditions of any Chapter 99 provision and any applicable regulations or orders in relation thereto have been met. 4. The words and expressions used in this Chapter have the same meaning as in Chapters 1 to 97. Issued January 1, 2019 99 - 1 CUSTOMS TARIFF - SCHEDULE Tariff Unit of MFN Applicable SS Description of Goods Item Meas. Tariff Preferential Tariffs 9901.00.00 Articles and materials for use in the manufacture or repair of the Free CCCT, LDCT, GPT, UST, following to be employed in commercial fishing or the commercial MT, MUST, CIAT, CT, harvesting of marine plants: CRT, IT, NT, SLT, PT, COLT, JT, PAT, HNT, Artificial bait; KRT, CEUT, UAT, CPTPT: Free Carapace measures; Cordage, fishing lines (including marlines), rope and twine, of a circumference not exceeding 38 mm; Devices for keeping nets open; Fish hooks; Fishing nets and netting; Jiggers; Line floats; Lobster traps; Lures; Marker buoys of any material excluding wood; Net floats; Scallop drag nets; Spat collectors and collector holders; Swivels.
    [Show full text]
  • Figure S1. Flow Chart to Present the Experimental Design of the Present Study
    Figure S1. Flow chart to present the experimental design of the present study. Figure S2. Volcano plot showing the differentially expressed genes between papillary renal cell carcinoma and non-cancer adjacent samples. Figure S3. The 2D molecular structures of the top 10 drugs. Table SI. The 60 potential drugs for papillary renal cell carcinoma treatment based on differently expressed genes. Drug name Dose Cell line Score Instance ID Pinacidil (C13H19N5) 16 µM HL60 -1 2406 Ciclosporin (C62H111N11O12) 3 µM HL60 -0.994 1331 Naftifine (C21H21N) 12 µM HL60 -0.966 2974 Vorinostat (C14H20N2O3) 10 µM HL60 -0.961 1161 Metacycline (C22H22N2O8) 8 µM HL60 -0.943 2901 Sulfacetamide (C8H10N2O3S) 16 µM HL60 -0.939 1859 Chlorprothixene (C18H18ClNS) 11 µM HL60 -0.938 1272 Amiodarone (C25H29I2NO3) 6 µM HL60 -0.933 2434 Noretynodrel (C20H26O2) 13 µM HL60 -0.914 1860 Valproic acid (C8H16O2) 200 µM HL60 -0.91 1155 Oxolinic acid (C13H11NO5) 15 µM HL60 -0.903 1419 Monocrotaline (C16H23NO6) 12 µM PC3 -0.881 7127 LY-294002 (C19H17NO3) 10 µM HL60 -0.869 1168 Aceclofenac (C16H13Cl2NO4) 11 µM PC3 -0.863 7269 Hyoscyamine (C17H23NO3) 14 µM HL60 -0.859 1424 Heliotrine (C16H27NO5) 13 µM HL60 -0.85 2180 Trichostatin A (C17H22N2O3) 1 µM HL60 -0.85 1175 Sulfachlorpyridazine (C10H8ClN4O2S) 14 µM HL60 -0.85 2191 Diflorasone (C22H28F2O5) 8 µM HL60 -0.838 2142 Yohimbine (C21H26N2O3) 10 µM MCF7 -0.833 6777 Sulfadiazine (C10H10N4O2S) 16 µM HL60 -0.833 1852 Pargyline (C11H13N) 20 µM PC3 -0.832 2102 Haloperidol (C21H23ClFNO2) 10 µM HL60 -0.829 6203 Methazolamide (C5H8N4O3S2) 17
    [Show full text]
  • European Surveillance of Healthcare-Associated Infections in Intensive Care Units
    TECHNICAL DOCUMENT European surveillance of healthcare-associated infections in intensive care units HAI-Net ICU protocol Protocol version 1.02 www.ecdc.europa.eu ECDC TECHNICAL DOCUMENT European surveillance of healthcare- associated infections in intensive care units HAI-Net ICU protocol, version 1.02 This technical document of the European Centre for Disease Prevention and Control (ECDC) was coordinated by Carl Suetens. In accordance with the Staff Regulations for Officials and Conditions of Employment of Other Servants of the European Union and the ECDC Independence Policy, ECDC staff members shall not, in the performance of their duties, deal with a matter in which, directly or indirectly, they have any personal interest such as to impair their independence. This is version 1.02 of the HAI-Net ICU protocol. Differences between versions 1.01 (December 2010) and 1.02 are purely editorial. Suggested citation: European Centre for Disease Prevention and Control. European surveillance of healthcare- associated infections in intensive care units – HAI-Net ICU protocol, version 1.02. Stockholm: ECDC; 2015. Stockholm, March 2015 ISBN 978-92-9193-627-4 doi 10.2900/371526 Catalogue number TQ-04-15-186-EN-N © European Centre for Disease Prevention and Control, 2015 Reproduction is authorised, provided the source is acknowledged. TECHNICAL DOCUMENT HAI-Net ICU protocol, version 1.02 Table of contents Abbreviations ...............................................................................................................................................
    [Show full text]
  • Using Saccharomyces Cerevisiae for the Biosynthesis of Tetracycline Antibiotics
    Using Saccharomyces cerevisiae for the Biosynthesis of Tetracycline Antibiotics Ehud Herbst Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the Graduate School of Arts and Sciences COLUMBIA UNIVERSITY 2019 © 2019 Ehud Herbst All rights reserved ABSTRACT Using Saccharomyces cerevisiae for the biosynthesis of tetracycline antibiotics Ehud Herbst Developing treatments for antibiotic resistant bacterial infections is among the most urgent public health challenges worldwide. Tetracyclines are one of the most important classes of antibiotics, but like other antibiotics classes, have fallen prey to antibiotic resistance. Key small changes in the tetracycline structure can lead to major and distinct pharmaceutically essential improvements. Thus, the development of new synthetic capabilities has repeatedly been the enabling tool for powerful new tetracyclines that combatted tetracycline-resistance. Traditionally, tetracycline antibiotics were accessed through bacterial natural products or semisynthetic analogs derived from these products or their intermediates. More recently, total synthesis provided an additional route as well. Importantly however, key promising antibiotic candidates remained inaccessible through existing synthetic approaches. Heterologous biosynthesis is tackling the production of medicinally important and structurally intriguing natural products and their unnatural analogs in tractable hosts such as Saccharomyces cerevisiae. Recently, the heterologous biosynthesis of several tetracyclines was achieved in Streptomyces lividans through the expression of their respective biosynthetic pathways. In addition, the heterologous biosynthesis of fungal anhydrotetracyclines was shown in S. cerevisiae. This dissertation describes the use of Saccharomyces cerevisiae towards the biosynthesis of target tetracyclines that have promising prospects as antibiotics based on the established structure- activity relationship of tetracyclines but have been previously synthetically inaccessible.
    [Show full text]
  • Adsorption of Tetracycline by a Tailor- Made Adsorbent in Aqueous System
    Journal of Applied Biotechnology & Bioengineering Research Article Open Access Adsorption of tetracycline by a tailor- made adsorbent in aqueous system Abstract Volume 6 Issue 1 - 2019 Tetracyclines are frequently used antibiotics for growth promotion and therapeutic Adelagun Ruth Olubukola Ajoke pharmaceuticals both by humans and animal husbandry, and commonly encountered in Department of Chemical Sciences, Federal University, Nigeria municipal wastewater treatment plants and in the environment in their active form. This implies their continuous release into the environment may facilitate toxic effects both Correspondence: Adelagun Ruth Olubukola Ajoke, on humans and the environment including development of resistance strains, among Department of Chemical Sciences, Federal University, Wukari, others. This research was focused on the synthesis, characterisation and assessment Nigeria, Email of a tailor- made adsorbent: modified chitosan flakes, using several materials for the modification of chitosan to enhance its sorption properties thereby facilitating a higher Received: December 24, 2018 | Published: February 01, 2019 percentage of TC removal from a synthetic pharmaceutical wastewater. TC adsorption onto the modified chitosan flakes was relatively fast (equilibrium time = 2h). Sorption studies revealed that TC removal by the adsorbent followed pseudo second order kinetics and Freundlich isotherm models. At higher TC input concentration, the amount of TC removed was also higher, this implied the sorption was concentration dependent.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies
    Arrhythmogenic potential of drugs FP7-HEALTH-241679 http://www.aritmo-project.org/ Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies V 1.3 Draft Lead beneficiary: EMC Date: 03/01/2010 Nature: Report Dissemination level: D5.2 Report on Common Study Protocol for Observational Database Studies WP5: Conduct of Additional Observational Security: Studies. Author(s): Gianluca Trifiro’ (EMC), Giampiero Version: v1.1– 2/85 Mazzaglia (F-SIMG) Draft TABLE OF CONTENTS DOCUMENT INFOOMATION AND HISTORY ...........................................................................4 DEFINITIONS .................................................... ERRORE. IL SEGNALIBRO NON È DEFINITO. ABBREVIATIONS ......................................................................................................................6 1. BACKGROUND .................................................................................................................7 2. STUDY OBJECTIVES................................ ERRORE. IL SEGNALIBRO NON È DEFINITO. 3. METHODS ..........................................................................................................................8 3.1.STUDY DESIGN ....................................................................................................................8 3.2.DATA SOURCES ..................................................................................................................9 3.2.1. IPCI Database .....................................................................................................9
    [Show full text]
  • Statistical Analysis Plan / Data Specifications the Risk of Acute Liver Injury Associated with the Use of Antibiotics. a Replica
    WP6 validation on methods involving an extended audience Statistical analysis plan / data specifications The risk of acute liver injury associated with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database Version: July 11, 2013 Authors: Renate Udo, Marie L De Bruin Reviewers: Work package 6 members (David Irvine, Stephany Tcherny-Lessenot) 1 1. Context The study described in this protocol is performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium). The overall objective of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. Work package 6 “validation on methods involving an extended audience” aims to test the transferability/feasibility of methods developed in other WPs (in particular WP2 and WP5) in a range of data sources owned or managed by Consortium Partners or members of the Extended Audience. The specific aims of this study within WP6 are: to evaluate the external validity of the study protocol on the risk of acute liver injury associated with the use of antibiotics by replicating the study protocol in another database, to study the impact of case validation on the effect estimate for the association between antibiotic exposure and acute liver injury. Of the selected drug-adverse event pairs selected in PROTECT, this study will concentrate on the association between antibiotic use and acute liver injury. On this topic, two sub-studies are performed: a descriptive/outcome validation study and an association study. The descriptive/outcome validation study has been conducted within the Utrecht Patient Oriented Database (UPOD).
    [Show full text]
  • Critically Important Antimicrobials for Human Medicine – 5Th Revision. Geneva
    WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) Critically Important Antimicrobials for Human Medicine 5th Revision 2016 Ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use Critically important antimicrobials for human medicine – 5th rev. ISBN 978-92-4-151222-0 © World Health Organization 2017, Updated in June 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/ igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Critically important antimicrobials for human medicine – 5th rev. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
    [Show full text]