Martindale the Complete Drug Reference
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By in Vivo's Biopharma, Medtech and Diagnostics Teams
invivo.pharmaintelligence.informa.com JANUARY 2018 Invol. 36 ❚ no. 01 Vivopharma intelligence ❚ informa 2018 OUTLOOK By In Vivo’s Biopharma, Medtech and Diagnostics Teams PAGE LEFT BLANK INTENTIONALLY invivo.pharmaintelligence.informa.com STRATEGIC INSIGHTS FOR LIFE SCIENCES DECISION-MAKERS CONTENTS ❚ In Vivo Pharma intelligence | January 2018 BIOPHARMA MEDTECH 2018 DIAGNOSTICS OUTLOOK 12 22 28 Biopharma 2018: Medtech 2018: Diagnostics 2018: Is There Still A Place For Pharma The Place For Innovation Steady Progress And In The New Health Care As Value-based Health Care The Big Get Bigger Economy? Gains Momentum MARK RATNER WILLIAM LOONEY ASHLEY YEO If the beginning of 2017 was marked 2018 will be a time of transition in health 2017 was a watershed year in many by doubts around whether and how care, when biopharma’s counterparts respects, politically, economically the FDA would act with respect to in adjacent industry segments scale up and commercially for many players complex diagnostics, we enter 2018 in a radical redesign of their traditional in the medtech field. Where will the feeling that slow-moving vessel may business models. Biopharma is not opportunities lie in 2018? Will finally be turning. moving as quickly, and it confronts a breakthrough medtech innovation still strategic dilemma on how to address the have a place among providers often prospect of a much more powerful set of riding on fumes when it comes to 36 rivals in the ongoing battle to own the budgets, and is it all as bad as some patient experience in medicine. would make out? Thirty-five Years Covering Health Care: The More Things Change… 30 PETER CHARLISH A Virtuous Cycle: What The The health care industry has come a Immuno-Oncology Revolution long way in the past 35 years, although Means For Other Disease Areas in some areas very little has changed. -
Appendix 1 Definitions of Words and Phrases Used in the Act And
Appendix 1 Definitions of Words and Phrases Used in the Act and Subordinate Legislation The persons responsible for drafting a piece of legislation aim to achieve clarity and avoid ambiguity in the document. However, most words have shades of meaning and the interpretation of the statute or instrument becomes difficult for those who have to obey or enforce it, especially when such persons are not law yers. In the last analysis, it is a judge who has to decide whether a particular set of circumstances fall within or outside a given set of words, but this may be too late for the citizen who may have done utmost to keep within the law. It should, however, be pointed out that government departments and others who have a duty to enforce a piece of legislation are usually willing to advise members of the public as to its meaning and effects. In order to help those who have to obey or enforce the law an 'interpretation' section, regulation or rule containing a number of technical terms used in the document is often included. In the Medicines Act, sections 130,131 and 132 are devoted to this purpose. However, many other terms are defined in other sec tions and are sometimes less easy to locate. Furthermore, numerous statutory instruments also define various words and phrases and these definitions are not always identical with those used in the Act. To facilitate reference to these defi nitions, they have been collected together and printed alphabetically with the exception of 'medicinal product' and 'wholesale' and 'retail' sale which, in view of their importance, are treated separately. -
Therapeutic Consequences of the Drug Lag 93 X Recent Developments, 1972 to 1974 ...•
REGULATION AND DRUG DEVELOPMENT William M. Wardell and Louis Lasagna American Enterprise Institute for Public Policy Research Washington. D. C. CONTENTS INTRODUCTION .. ................... 1 PART ONE Science. Government, and the Current State of Affairs I PRE-1962 PRACTICES: THE EVOLUTION OF CON- TROLS OVER THERAPEUTIC DRUGS 5 II POST-1962 GUIDELINES AND PRACTICES 19 III THE NATURE OF EVIDENCE 27 IV WEIGHING THE EVIDENCE 37 V ECONOMICS AND DRUG DEVELOPMENT 45 PART TWO Lessons from Other Countries VI APPROACHES TO INTERNATIONAL COMPARISONS 51 VII PATTERNS OF INTRODUCTION OF NEW DRUGS IN BRITAIN AND THE UNITED STATES 55 VIII BRITISH USAGE AND AMERICAN AWARENESS OF SOME NEW DRUGS 79 IX THERAPEUTIC CONSEQUENCES OF THE DRUG LAG 93 X RECENT DEVELOPMENTS, 1972 TO 1974 ...•....... 109 PART THREE The Wider Issues XI THE INTENT OF CONGRESS AND THE NEEDS OF PATIENTS 127 XII THE RUBRICS REEXAMINED 135 XIII SUGGESTIONS FOR IMPROVEMENT. ............. .. 143 XIV CONCLUSIONS.................................... 161 APPENDIX: Definition of "Substantial Evidence" 167 NOTES 171 INTRODUCTION In the late 1950s the Congress of the United States began holding subcommittee hearings on various matters pertaining to the pharma ceutical industry. Two of the most vigorous and sensational were those chaired by Congressman Blatnik and by Senator Kefauver. They were highly critical of the quality of drug advertising, theevi dence for effectiveness of marketed pharmaceuticals, the allegedly monopolistic nature of the drug industry, and the price of medicines. The drug industry, accustomed to respect and gratitude from physicians and the public, was suddenly confronted with hostile, sensational newspaper headlines and stories and a rising wave of angry criticism. -
An Expert System for Development of Powder Filled Hard Gelatin Capsule Formulations
An Expert System For Development of Powder Filled Hard Gelatin Capsule Formulations Thesis submitted to the University of London Faculty of Medicine for THE DEGREE OF DOCTOR OF PHILOSOPHY ky Samantha Miu Ha Lai B.Pharm., M.R.Pharm.S. September 1996 The School of Pharmacy University of London Brunswick Square London WCIN lAX ProQuest Number: 10104253 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 10104253 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 Father ACKNOWLEDGMENT I would like to dedicate this thesis to my father, without whom I would not be able to achieve this PhD. My sister, Esther and my boyfriend, Eric were also very understanding and have been most supportive throughout my ‘ups and downs’. The guidance and supervision provided by my supervisor. Professor J M Newton and also by Dr F Podczeck also made this PhD possible. Special thanks must go to Professor Newton for being so incredibly patient and spending so much time with me on top of his busy schedule. -
International Nonproprietary Names (Inns) to Medicines
WWW.CIOMS.CH Special Newsletter | 29 August 2018 This is the first of a series of special newsletters describing the work of CIOMS member organizations and partners. It describes the programme within the World Health Organization (WHO) that assigns International Nonproprietary Names (INNs) to medicines. The WHO INN Programme: International Nonproprietary Names for pharmaceutical substances With tens of thousands of medicines on the market, confusion between Medicine names: a safety issue medicine names can have serious consequences for patient safety. How INNs are defined WHO assigns single, unique, globally accepted names to INNs – a map to medicines classes pharmaceutical substances. The International Nonproprietary Names The INN MedNet (INN) nomenclature provides a common language for people all over The School of INN (SoINN) the world—including the CIOMS Working Groups—to work together for INNs for better medicines use the safe and effective use of medicines. Medicine names: a safety issue This variety of names can cause confusion, which A medicine can be identified in different ways: by its might lead to medication errors. brand name (“Aspirin”) or its chemical name Patient safety is a primary concern of WHO. In (acetylsalicylic acid). Furthermore, historically some 1950 the Organization established the INN regulatory authorities have approved nonproprietary Programme for pharmaceutical substances to names for pharmaceuticals in their jurisdictions (e.g., mitigate the risk of name confusions and medication paracetamol in Europe, acetaminophen in the US). errors. The main objective of the programme is to A brand name can designate a medicine containing define a single, unique, globally accepted name for more than one active substance, and often the same each pharmaceutical substance. -
204200Orig1s000 204200Orig2s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204200Orig1s000 204200Orig2s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 204-200 and 204-640 Priority or Standard Standard Submit Date(s) March 7, 2012 Received Date(s) March 7, 2012 PDUFA Goal Date January 7, 2013 Division / Office DPARP/OND Reviewer Name(s) Peter Starke, MD Review Completion Date October 29, 2012 Established Name Epinephrine injection, USP, 1mg/mL (Proposed) Trade Name Adrenalin® Therapeutic Class Catecholamine Applicant JHP Pharmaceuticals, LLC Formulation(s) Solution for injection Proposed Dosing Hypersensitivity reactions: IM or SC Regimen injection(b) (4) [Ophthalmic use: Topical irrigation or intraocular bolus injection] Proposed Indication(s) Hypersensitivity reactions: severe acute anaphylactic reactions, (b) (4) [Ophthalmic use: induction and maintenance of mydriasis during cataract surgery] Intended Population(s) Hypersensitivity reactions: No age restrictions [Ophthalmic use: No age restrictions] Reference ID: 3209828 Clinical Review ● Peter Starke, MD NDA 204-200 ● Adrenalin® (epinephrine) MEDICAL OFFICER REVIEW Division of Pulmonary, Allergy and Rheumatology Products (DPARP) SUBMISSIONS REVIEWED IN THIS DOCUMENT Document Date CDER Stamp Date Submission Comments March 7, 2012 March 7, 2012 SD-1, eCTD-0000 New NDA submission April 9, 2012 April 9, 2012 SD-2, eCTD-0001 PREA waiver request – Anaphylaxis April 9, 2012 April 9, 2012 SD-3, eCTD-0002 PREA waiver request – Mydriasis April 18, 2012 April 18, 2012 SD-4, eCTD-0003 Request for proprietary name review Sept 5, 2012 Sept 6, 2012 SD-22, eCTD-0021 Draft Ophthalmic Labeling Oct 22, 2012 Oct 22, 2012 SD-27, eCDT-0026 Certification that EpiPen is the reference for the 505(b)(2) application RECOMMENDED REGULATORY ACTION NDA/SUPPLEMENTS: X APPROVAL COMPLETE RESPONSE OTHER ACTION: 2 Reference ID: 3209828 Clinical Review ● Peter Starke, MD NDA 204-200 ● Adrenalin® (epinephrine) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ........................................ -
A Convenient Synthesis of the Side Chain of Loteprednol
Steroids 76 (2011) 497–501 Contents lists available at ScienceDirect Steroids journal homepage: www.elsevier.com/locate/steroids A convenient synthesis of the side chain of loteprednol etabonate—An ocular soft corticosteroid from 20-oxopregnanes using metal-mediated halogenation as a key reaction Pritish Chowdhury ∗, Juri Moni Borah, Papori Goswami 1, Archana Moni Das Natural Products Chemistry Division, North East Institute of Science & Technology, Jorhat 785 006, Assam, India article info abstract Article history: A facile synthesis of the side chain of loteprednol etabonate, namely, chloromethyl-17␣-[(ethoxy- Received 23 August 2010 carbonyl))oxy]-11-hydro of loteprednol etabonate, viz., chloromethyl-17␣-[(ethoxycarbonyl))oxy]- Received in revised form 11xy-3-oxoandrosta-1,4-diene-17-carboxylate – an ocular soft corticosteroid, has been described start- 23 December 2010 ing from a 20-oxopregnane, namely, 3-acetoxy-pregn-5(6),16(17)-diene-20-one (16-dehydropregne- Accepted 17 January 2011 nolone acetate, i.e., 16-DPA) using our recently developed metal-mediated halogenation as a key reaction. Available online 26 January 2011 © 2011 Elsevier Inc. All rights reserved. Keywords: Loteprednol etabonate Soft corticosteroid 16-DPA Metal mediated halogenation Anti-inflammatory agents Corticosteroids have demonstrated excellent anti-inflammatory In loteprednol etabonate, a metabolically labile ester function activity in clinical practice. However, their therapeutic effects are occupies a 17-position, while a stable carbonate group occu- often accompanied by toxicity [1]. Hence, the search for improved pies the 17␣-position. The ester is hydrolysed to an inactive topical corticosteroids with less toxicity has been a major goal in carboxylic acid, 1-cortienic acid etabonate, and then into 1- pharmaceutical research and development in recent years. -
Drug Discovery: a History
________________________________________________________________________________________________________________________ ______________________________ Drug Discovery A History Walter Sneader School of Pharmacy University of Strathclyde, Glasgow, UK ________________________________________________________________________________________________________________________ ______________________________ Drug Discovery ________________________________________________________________________________________________________________________ ______________________________ Drug Discovery A History Walter Sneader School of Pharmacy University of Strathclyde, Glasgow, UK Copyright u 2005 John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex PO19 8SQ, England Telephone (+44) 1243 779777 Email (for orders and customer service enquiries): [email protected] All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning or otherwise, except under the terms of the Copyright, Designs and Patents Act 1988 or under the terms of a licence issued by the Copyright Licensing Agency Ltd, 90 Tottenham Court Road, London W1T 4LP, UK, without the permission in writing of the Publisher. Requests to the Publisher should be addressed to the Permissions Department, John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex PO19 8SQ, England, or emailed to [email protected], or faxed to (+44) 1243 -
ABSTRACT This Material Provides Documentation for Users of the Micro-Data Files of the 2000 National Hospital Ambulatory Medical
2000 NHAMCS MICRO-DATA FILE DOCUMENTATION PAGE 1 ABSTRACT This material provides documentation for users of the micro-data files of the 2000 National Hospital Ambulatory Medical Care Survey (NHAMCS). The NHAMCS is a national probability sample survey of visits to hospital outpatient and emergency departments, conducted by the National Center for Health Statistics, Centers for Disease Control and Prevention. The survey is a component of the National Health Care Survey, which measures health care utilization across a variety of health care providers. There are two micro-data files produced from the NHAMCS, one for outpatient department records and one for emergency department records. Section I of this documentation, “Description of the National Hospital Ambulatory Medical Care Survey,” includes information on the scope of the survey, the sample, field activities, data collection procedures, medical coding procedures, and population estimates. Section II provides detailed descriptions of the contents of each file’s data record by location. Section III contains marginal data for selected items on each file. The appendixes contain sampling errors, instructions and definitions for completing the Patient Record forms, and lists of codes used in the survey. PAGE 2 2000 NHAMCS MICRO-DATA FILE DOCUMENTATION THIS PAGE HAS BEEN LEFT BLANK INTENTIONALLY. 2000 NHAMCS MICRO-DATA FILE DOCUMENTATION PAGE 3 Table of Contents Page I. Description of the National Hospital Ambulatory Medical Care Survey A. Introduction ..........................................................5 -
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. -
Pharmaceutical Advertising 2017
ICLGThe International Comparative Legal Guide to: Pharmaceutical Advertising 2017 14th Edition A practical cross-border insight into pharmaceutical advertising Published by Global Legal Group, with contributions from: Allen & Gledhill LLP Jones Day ALRUD Jusmedico Advokatanpartsselskab Arnold & Porter Kaye Scholer LLP Kyriakides Georgopoulos Law Firm Arthur Cox LCH Law Compliance Health Baker & McKenzie Life Sciences Legal Biolato Longo Ridola & Mori Mannheimer Swartling Advokatbyrå Clayton Utz Nishimura & Asahi Clifford Chance Norton Rose Fulbright Canada LLP Cuatrecasas OLIVARES Deep & Far Attorneys-at-Law Pestalozzi Attorneys at Law Gorodissky & Partners (Ukraine) Quinz Gün + Partners Roschier, Attorneys Ltd. Haavind Sołtysiński Kawecki & Szlęzak Herbst Kinsky Rechtsanwälte GmbH Subramaniam & Associates (SNA) The International Comparative Legal Guide to: Pharmaceutical Advertising 2017 General Chapter: 1 Off-label Use: Current Position in the EU and U.S. – Jackie Mulryne & Mahnu Davar, Arnold & Porter Kaye Scholer LLP 1 Contributing Editor Country Question and Answer Chapters: Ian Dodds-Smith, Arnold & 2 Australia Clayton Utz: Colin Loveday & Greg Williams 7 Porter Kaye Scholer LLP Sales Director 3 Austria Herbst Kinsky Rechtsanwälte GmbH: Dr. Sonja Hebenstreit & Florjan Osmani Dr. Isabel Funk-Leisch 20 Account Director Oliver Smith 4 Belgium Quinz: Olivier Van Obberghen & Joris Beke 33 Sales Support Manager 5 Canada Norton Rose Fulbright Canada LLP: Sara Zborovski & Ian Trimble 43 Paul Mochalski Editor 6 China Jones Day: Chiang Ling Li & Haifeng Huang 53 Caroline Collingwood 7 Denmark Jusmedico Advokatanpartsselskab: Jan Bjerrum Bach & Lone Hertz 63 Senior Editors Suzie Levy, Rachel Williams 8 England & Wales Arnold & Porter Kaye Scholer LLP: Adela Williams & Silvia Valverde 80 Chief Operating Officer Dror Levy 9 Finland Roschier, Attorneys Ltd.: Mikael Segercrantz & Johanna Lilja 95 Group Consulting Editor 10 France LCH Law Compliance Health: Laure Le Calvé & Johanna Benichou 106 Alan Falach Publisher 11 Germany Clifford Chance: Dr. -
(INN) for Pharmaceutical Substances Names for Radicals, Groups & Others
WHO/PSM/QSM/2007.1 International Nonproprietary Names (INN) for pharmaceutical substances Names for radicals, groups & others comprehensive list 2007 International Nonproprietary Names (INN) Programme Quality Assurance and Safety: Medicines Medicines Policy and Standards WHO/PSM/QSM/2007.1 International Nonproprietary Names (INN) for pharmaceutical substances Names for radicals, groups & others comprehensive list 2007 International Nonproprietary Names (INN) Programme Quality Assurance and Safety: Medicines Medicines Policy and Standards International Nonproprietary Names (INN) for pharmaceutical substances. Names for radicals, groups & others : comprehensive list © World Health Organization 2007 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.