DOCSLIB.ORG

Statistical Analysis Plan: IT001-302

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Statistical Analysis Plan: IT001-302 Statistical Analysis Plan: IT001-302 Study Title: A prospective, Phase 3, randomized, multi-center, double-blind, double dummy study of the efficacy, tolerability and safety of intravenous sulopenem followed by oral sulopenem-etzadroxil with probenecid versus intravenous ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate for treatment of complicated urinary tract infections in adults. Study Number: IT001-302 Study Phase: Phase 3 Product Name: Sulopenem (CP-70,429), Sulopenem-etzadroxil (PF-03709270)/Probenecid Indication: Complicated urinary tract infection Study Statistician: Michael Zelasky Study Clinician: Steven I. Aronin, M.D. Sponsor: Iterum Therapeutics International Limited 20 Research Parkway, Suite A Old Saybrook, CT 06475 Final SAP Date: September 25, 2019 Revised SAP Date: February 11, 2020 Protocol Version: January 16, 2020 Confidentiality Statement This document is strictly confidential. It was developed by Iterum Therapeutics US Limited should not be disclosed to a third party, with the exception of regulatory agencies and study audit personnel. Reproduction, modification or adaptation, in part or in total, is strictly forbidden without prior written approval by Iterum Therapeutics US Limited Digitally signed by Anita F Das DN: cn=Anita F Das, o, ou, [email protected]. Anita F Das com, c=US Date: 2020.02.12 12:57:12 -08'00' Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 TABLE OF CONTENTS TABLE OF CONTENTS............................................................................................................ 3 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS............................................. 5 1 INTRODUCTION............................................................................................................. 7 2 STUDY DESIGN............................................................................................................... 7 3 STUDY OBJECTIVES..................................................................................................... 7 3.1 Primary Objective ................................................................................................. 7 3.2 Secondary Objectives ........................................................................................... 7 4 DEFINITION OF ANALYSIS POPULATIONS........................................................... 8 4.1 Intent-to-Treat (ITT)............................................................................................ 8 4.2 Modified Intent-to-Treat (MITT) ....................................................................... 8 4.3 Microbiological Modified Intent-to-Treat (micro-MITT or m-MITT)......... 8 4.4 Clinical Evaluable (CE) ......................................................................................... 8 4.5 Microbiological Evaluable (ME)......................................................................... 9 4.6 Safety ....................................................................................................................... 9 4.7 Determination of Inclusion in Analysis Populations................................... 10 5 DEFINITION OF OUTCOMES ................................................................................... 10 5.1 Overall Response................................................................................................... 10 5.2 Microbiologic Response........................................................................................ 11 5.2.1 Baseline Pathogens................................................................................................ 11 5.2.2 Post-Baseline Pathogens ....................................................................................... 13 5.3 Patient-Determined Clinical Response (Clinical Response) ............................. 14 5.4 Investigator-Determined Clinical Response:...................................................... 15 5.5 Patient Symptom Assessment Questionnaire (PSAQ)....................................... 15 5.6 Other Signs and Symptoms.................................................................................. 16 5.7 Safety Outcome Measures.................................................................................. 16 6 STATISTICAL METHODS .......................................................................................... 16 6.1 Sample Size........................................................................................................... 16 6.2 Randomization ...................................................................................................... 17 6.3 Visit Windows........................................................................................................ 17 6.4 Microbiology Data ................................................................................................ 17 6.5 Handling of Missing Data..................................................................................... 18 6.6 Comments on Statistical Analysis........................................................................ 20 7 STATISTICAL ANALYSES ......................................................................................... 21 Confidential 3 Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 7.1 Patient Disposition ................................................................................................ 21 7.2 Demographics and Baseline Characteristics ...................................................... 21 7.2.1 Baseline Microbiology.................................................................................. 22 7.3 Prior and Concomitant Medications................................................................... 22 7.4 Study Drug Exposure ........................................................................................... 23 7.5 Efficacy Analyses .................................................................................................. 23 7.5.1 Primary Efficacy Analysis.................................................................................... 23 7.5.2 Additional Analyses of the Primary Efficacy Outcome..................................... 24 7.5.3 Secondary Efficacy Analysis................................................................................ 26 7.5.4 Additional Efficacy Analyses ............................................................................... 26 7.6 Interim Analysis.................................................................................................... 31 7.7 Safety Analyses...................................................................................................... 32 7.7.1 Adverse Events...................................................................................................... 32 7.7.1.1 Diarrhea Episodes................................................................................................. 32 7.7.2 Laboratory Values ................................................................................................ 33 7.7.3 Physical Examinations.......................................................................................... 34 7.7.4 Vital Signs.............................................................................................................. 34 7.8 Protocol Deviations ............................................................................................... 35 8 DIFFERENCES WITH ANALYSES SPECIFIED IN THE PROTOCOL............... 36 9 REFERENCES................................................................................................................ 37 Appendix A: Schedule of Activities ............................................................................. 38 Appendix B: Criteria for Safety Values of Potential Clinical Concern........................ 40 Appendix C: Method for Determination of Creatinine Clearance................................ 41 Appendix D: Microbiology Rules for Determination of Final Pathogen ..................... 42 Confidential 4 Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS AE Adverse Event BMI Body Mass Index CE Clinical Evaluable CFU Colony Forming Unit CI Confidence Interval CRF Case Report Form CSR Clinical Study Report cUTI Complicated Urinary Tract Infection EOT End of Treatment Visit ESBL Extended-6SHFWUXPȕ-Lactamases FDA Food and Drug Administration FV Final Visit GCP Good Clinical Practice IA Interim Analysis ITT Intent-to-Treat IWRS Interactive Web Response System m-MITT Microbiological Modified Intent-to-Treat ME Microbiological Evaluable MedDRA Medical Dictionary for Regulatory Activities MG Milligram MIC Minimum Inhibitory Concentration micro-MITT Microbiological Modified Intent-to-Treat MITT Modified Intent-to-Treat NDA New Drug Application Confidential 5 Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 PD Pharmacodynamic PK Pharmacokinetic PO Orally PSAQ Patient Symptom Assessment Questionnaire SAE serious adverse event SAP Statistical Analysis Plan SD standard deviation SE standard error Tfree>MIC Time of free concentration above MIC TOC Test of Cure Visit WHODRUG World Health Organization (WHO) Drug Dictionary Confidential 6 Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 1 INTRODUCTION
Load more

Recommended publications
  • Topical and Systemic Antifungal Therapy for Chronic Rhinosinusitis (Protocol)
    CORE Metadata, citation and similar papers at core.ac.uk Provided by University of East Anglia digital repository Cochrane Database of Systematic Reviews Topical and systemic antifungal therapy for chronic rhinosinusitis (Protocol) Head K, Sacks PL, Chong LY, Hopkins C, Philpott C Head K, Sacks PL, Chong LY, Hopkins C, Philpott C. Topical and systemic antifungal therapy for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD012453. DOI: 10.1002/14651858.CD012453. www.cochranelibrary.com Topical and systemic antifungal therapy for chronic rhinosinusitis (Protocol) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 BACKGROUND .................................... 1 OBJECTIVES ..................................... 3 METHODS ...................................... 3 ACKNOWLEDGEMENTS . 8 REFERENCES ..................................... 9 APPENDICES ..................................... 10 CONTRIBUTIONSOFAUTHORS . 25 DECLARATIONSOFINTEREST . 26 SOURCESOFSUPPORT . 26 NOTES........................................ 26 Topical and systemic antifungal therapy for chronic rhinosinusitis (Protocol) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Topical and systemic antifungal therapy for chronic rhinosinusitis Karen Head1, Peta-Lee Sacks2, Lee Yee Chong1, Claire Hopkins3, Carl Philpott4 1UK Cochrane Centre,
    [Show full text]
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • Metronidazole/Nifuratel 841
    Metronidazole/Nifuratel 841 African trypanosomiasis. Although there is no established al- Monensin (BAN, USAN, rINN) Nicarbazin (BAN) ternative treatment for Trypanosoma brucei rhodesiense infec- Lilly-67314; Monensina; Monensinum. 4-{2-[2-Ethyl-3′-methyl- Nicarbazina. An equimolecular complex of 1,3-bis(4-nitro- tions that are resistant to melarsoprol (see p.827), metronidazole 5′-(tetrahydro-6-hydroxy-6-hydroxymethyl-3,5-dimethylpyran- phenyl)urea (C13H10N4O5) and 4,6-dimethylpyrimidin-2-ol 1 and suramin were effective in 1 patient. 2-yl)perhydro-2,2′-bifuran-5-yl]-9-hydroxy-2,8-dimethyl-1,6-di- (C6H8N2O). 1. Foulkes JR. Metronidazole and suramin combination in the treat- oxaspiro[4.5]dec-7-yl}3-methoxy-2-methylpentanoic acid. Никарбазин ment of arsenical refractory rhodesian sleeping sickness—a case Монензин C H N O = 426.4. study. Trans R Soc Trop Med Hyg 1996; 90: 422. 19 18 6 6 C36H62O11 = 670.9. CAS — 330-95-0. Preparations CAS — 17090-79-8. ATC Vet — QP51AE03. ATC Vet — QP51AH03. BP 2008: Metronidazole Gel; Metronidazole Intravenous Infusion; Metron- idazole Oral Suspension; Metronidazole Suppositories; Metronidazole Tab- lets; NHO CH3 USP 31: Metronidazole Gel; Metronidazole Injection; Metronidazole Tab- CH3 CH H lets. 3 N Proprietary Preparations (details are given in Part 3) O O- O- Arg.: Bexon; Colpofilin; Dazotron; Epaq†; Etronil; Flagyl; Format; Ginkan; H H CH3 OO + CH3 + Gynotran; Metral; Metrocev; Metrolocal; Nalox; Noritate†; Padet; Repligen; HO H3C N N Rozex; Taremis; Tolbin; Tricofin; Trimstat†; Austral.: Flagyl; Metrogyl;
    [Show full text]
  • Training Manual
    Training of Trainers Program on Analysis of Veterinary Drug Residues including Antibiotics TRAINING MANUAL Name: __________________________________ Email: __________________________________ Organized by: FSSAI & GFSP in association with PBTI at Punjab Biotechnology Incubator, Mohali, Punjab February, 2018 MANUAL FOR VETERINARY DRUG RESIDUE ANALYSIS INCLUDING ANTIBIOTICS Food Safety and Standards Authority of India Ministry of Health and Family Welfare, Government of India Manual for veterinary drug residue analysis including antibiotics, 2018. © 2018 by Food Safety and Standards Authority of India, New Delhi. All rights reserved. No part of this book may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical or photocopying, recording or otherwise without the prior written permission of the publisher or authors. ABOUT THE MANUAL The current manual borrows its majority of content and structure from the Training of Trainers (ToT) manual prepared by IFSTL partners USFDA, USDA and JIFSAN and with their consent. This manual is complementary to the workshop laboratory manual and lecture notes. The manual is meant to provide future trainers with an opportunity to make notes on various aspects of logistics associated with giving the training to a group. COPYRIGHT NOTICE The contents of the manual are protected by the terms of the Food Safety and Standard Authority of India (FSSAI), Ministry of Health and Family Welfare, Govt. of India. Permission to use whole or parts of texts contained in this manual in printed or electronic form must be obtained and is usually subject to royalty agreements. Proposals for non-commercial reproductions and translations are welcomed and considered on a case-by-case basis.
    [Show full text]
  • Use of Nifuratel to Treat Infections Caused by Atopobium Species
    (19) & (11) EP 2 243 482 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 27.10.2010 Bulletin 2010/43 A61K 31/422 (2006.01) A61P 15/02 (2006.01) A61P 31/04 (2006.01) A61P 13/02 (2006.01) (2006.01) (21) Application number: 09158221.3 A61P 15/00 (22) Date of filing: 20.04.2009 (84) Designated Contracting States: (72) Inventor: Mailland, Federico AT BE BG CH CY CZ DE DK EE ES FI FR GB GR CH-6900 Lugano (CH) HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK TR (74) Representative: Pistolesi, Roberto et al Designated Extension States: Dragotti & Associati Srl AL BA RS Via Marina 6 20121 Milano (IT) (71) Applicant: Polichem SA 1526 Luxembourg (LU) (54) Use of nifuratel to treat infections caused by atopobium species (57) The present invention is directed to the use of genitalia in both sexes, as well as bacterial vaginosis, or nifuratel, or a physiologically acceptable salt thereof, to mixed vaginal infections in women, when one or more treat infections caused by Atopobium species. The in- species of the genus Atopobium are among the causative vention is further directed to the use of nifuratel to treat pathogens of those infections. bacteriuria, urinary tract infections, infections of external EP 2 243 482 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 243 482 A1 Description [0001] The present invention relates to the use of nifuratel, or a physiologically acceptable salt thereof, to treat infections caused by Atopobium species.
    [Show full text]
  • Course Manual Division of Physiology, Nutrition and Pathology
    REFERENCE ONLY Mi' Winter School on 'RECENT ADVANCES IN DIAGNOSIS AND MANAGEMENT OF DISEASES Organising Committee IN MARICULTURE' Prof. (Dr) Mohan Joseph Modayil Director, CMFRI jth ^Q 27'^ November, 2002 Course Director Dr. K. C. George Principal Scientist, Course Manual Division of Physiology, Nutrition and Pathology Co-ordinators DP. R. Paul Raj, Head, P N P Division Dr. P. C. Thomas, Principal Scientist I C A R Shpi. N.K. Sanil, Scientist (Sr. Scale) Dr. (Mrs.) K.S. Sobhana, Scientist (Sr. Scale) Indian Council of Agricultural Research Central ^Aarine Fisheries Research Institute P B. No. 1603, Tatapuram P.O., Cochin 682 014 -gH4.|ffaT -r^mt Library •^ Qc^l^nf Mf,r,nc r^hcncs Rcso.rcn l,r tifirte Technical paper - 26 ANTIBIOTIC RESIDUES IN FARMED SHRIMP - A MAJOR HAZARD Dr.P.K. Surendran Head, Microbiology, Fermentation & Biotechnology Division Central Institute a/Fisheries Technology, Cochin-682 029 Antibiotics in aquaculture Even though use of antibiotics in aquaculture practice is unscientific, unwanted and harmful, antibiotics are being used for (i) therapeutic (ii) prophylactic and/or growth promoting purposes. Also, some manufactures are incorporating certain antibiotics in shrimp feed as a preservative. The devastating shrimp diseases like white spot syndrome disease and yellow head disease are caused by viruses. Antibiotics have no therapeutic value against viruses at all. Still many of our aquaculture farmers are dumping antibiotic formulations in their farms against viral diseases. Further, even bacterial diseases carmot be treated with antibiotics, since in the aquaculture environment, effectiveness of antibiotic therapy is not at all proved. The world over, use of antibiotics in aquaculture is banned.
    [Show full text]
  • Marrakesh Agreement Establishing the World Trade Organization
    No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX
    [Show full text]
  • Antimicrobial Activities of Nitrofurantoin and Some Novel Nitrofuran
    L Antim icFolDial activities of nitrofiiFantoin and some novel nitFofiiFan componnds X lie s i tm itte i io T lie University of Lon ty Catlierine A nn Skarpe £ Jegree of D octor of Pkilosopky Microbiology Section, Department of Pbarmaceutics, TLe School of Pharmacy, Brunswick Square, London 1 ProQuest Number: 10104255 All rights reserved INFORMATION TO ALL USERS The quality of this reproduction is dependent upon the quality of the copy submitted. In the unlikely event that the author did not send a complete manuscript and there are missing pages, these will be noted. Also, if material had to be removed, a note will indicate the deletion. uest. ProQuest 10104255 Published by ProQuest LLC(2016). Copyright of the Dissertation is held by the Author. All rights reserved. This work is protected against unauthorized copying under Title 17, United States Code. Microform Edition © ProQuest LLC. ProQuest LLC 789 East Eisenhower Parkway P.O. Box 1346 Ann Arbor, Ml 48106-1346 Dedicated to my parents M^argaret and. A llan Sliarpe Declaration and Acknowledgments The work presented in this thesis was carried out in the Microbiology Section of the Department of Pharmaceutics and in the Department of Pharmaceutical and Biological Chemistry at The School of Pharmacy, University of London between November 1994 and November 1997. During this period ten days were spent at laboratories of the Genetic and Reproductive Toxicology Department, Medicine Safety Evaluation Division of GlaxoWellcome in Ware, Hertfordshire. I would like to thank my supervisors Dr. R. J. Pinney and Dr. R. A. Watt for their substantial support and encouragement throughout this endeavour.
    [Show full text]
  • Diagnostic Value of Vaginal Discharge, Wet Mount and Vaginal
    DGGG Review 355 Diagnostic Value of Vaginal Discharge, Wet Mount and Vaginal pH – An Update on the Basics of Gynecologic Infectiology Was Fluor, Nativpräparat und pH-Wert verraten – Ein Update zu den Grundlagen der gynäkologischen Infektiologie Authors W. Frobenius1, C. Bogdan 2 Affiliations 1 Frauenklinik, Universitätsklinikum Erlangen, Erlangen 2 Mikrobiologisches Institut, Universitätsklinikum Erlangen, Erlangen Key words Abstract Zusammenfassung l" bacterial vaginosis ! ! l" vulvovaginal candidiasis The majority of uncomplicated vulvovaginal com- Die überwiegende Zahl unkomplizierter vulvo- l" trichomoniasis plaints (e.g. bacterial vaginosis, vulvovaginal can- vaginaler Beschwerden (z.B. bakterielle Vaginose, l" pelvic inflammatory disease didiasis, trichomoniasis) can be detected with un- Vulvovaginalkandidose, Trichomoniasis) lässt sich l" vaginal pH complicated basic infectiological tests and can durch eine einfache, infektiologische Basisunter- Schlüsselwörter usually be treated effectively without requiring suchung abklären und ohne weitergehende Diag- l" bakterielle Vaginose further diagnostic procedures. Tests include mea- nostik meist auch effektiv behandeln. Zu dieser l" Vulvovaginalkandidose surement of vaginal pH, preparation and assess- Untersuchung gehören die Messung des vagina- l" Trichomoniasis ment of wet mount slides prepared from vaginal len pH-Wertes, die Anfertigung und Beurteilung l" Pelvic inflammatory Disease l" vaginaler pH‑Wert or cervical discharge, and the correct clinical and eines Nativpräparats aus vaginalem bzw. zervi- microbiological classification of findings. In Ger- kalem Fluor sowie die korrekte Einordnung der many, at least in recent years, this has not been erhobenen Befunde in das klinische Bild und den sufficiently taught or practiced. As new regula- mikrobiologischen Kontext. Zumindest in tions on specialist gynecologic training in Ger- Deutschland wird dies seit Jahren zu wenig ge- Deutschsprachige many are currently being drawn up, this overview lehrt und praktiziert.
    [Show full text]
  • Evidence Review T
    National Institute for Health and Care Excellence Draft for consultation Antenatal care [T] Management of symptomatic vaginal discharge in pregnancy NICE guideline <number> Evidence reviews underpinning recommendations 1.4.7 to 1.4.11 February 2021 Draft for consultation These evidence reviews were developed by the National Guideline Alliance hosted by the Royal College of Obstetricians and Gynaecologists DRAFT FOR CONSULTATION Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive.
    [Show full text]
  • Impurity & Metabolite Catalogue.Pdf
    Table of Contents Table of Contents 1 About Carbosynth 2 How to Use this Catalogue 4 Key to Product Listing 5 Product Usage 5 How to Order 6 Prices 7 API Index 8 Alphabetical Listing by API 11 Formula Index 135 CAS Index 145 Product Code Index 151 Ring Numbering System 155 Catalogue Abbreviations 157 Terms of Sale 158 0800-251302 服務專線： The Source for Carbohydrates and Nucleosides 1 About Carbosynth Carbosynth is a specialist chemical company primarily working in the fields of carbohydrates, nucleosides and fine chemicals. We aim to offer a broad range of products to the international R&D communities in the following catalogues: Enzyme Substrate and Detergent Catalogue Monosaccharide Catalogue Oligosaccharide Catalogue Polysaccharide Catalogue and Handbook Nucleoside Catalogue Impurity and Metabolite Catalogue Fine Chemical Catalogue (CD format) Full Product Catalogue (CD format) The catalogues have over 30,000 products, of which over half are in stock. Although our catalogue listings are for R&D quantities, many are produced in bulk or can be scaled-up so we are happy to quote for semi-bulk and bulk quantities. In our labs we synthesise many of tht more complex catalogue products as well as undertaking custom synthesis work. Our focus is on the synthesis of complex carbohyrate building blokcs, glucuronides, nucleosides, phosphoramidites, mono- and tri-phosphates. In addition we offer a range of fine chemicals, many of which are versatile building blocks or have specialist applications ranging from biochemical reagents, API impurities, diagnostic reagents to natural antioxidants. The core te68chnologies include the synthesis of unnatural sugars and nucleosides that are of increasing interest to pharmaceutical and biotech discovery programs.
    [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]