2016 Prohibited List
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Part I Biopharmaceuticals
1 Part I Biopharmaceuticals Translational Medicine: Molecular Pharmacology and Drug Discovery First Edition. Edited by Robert A. Meyers. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA. Published 2018 by Wiley-VCH Verlag GmbH & Co. KGaA. 3 1 Analogs and Antagonists of Male Sex Hormones Robert W. Brueggemeier The Ohio State University, Division of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, Columbus, Ohio 43210, USA 1Introduction6 2 Historical 6 3 Endogenous Male Sex Hormones 7 3.1 Occurrence and Physiological Roles 7 3.2 Biosynthesis 8 3.3 Absorption and Distribution 12 3.4 Metabolism 13 3.4.1 Reductive Metabolism 14 3.4.2 Oxidative Metabolism 17 3.5 Mechanism of Action 19 4 Synthetic Androgens 24 4.1 Current Drugs on the Market 24 4.2 Therapeutic Uses and Bioassays 25 4.3 Structure–Activity Relationships for Steroidal Androgens 26 4.3.1 Early Modifications 26 4.3.2 Methylated Derivatives 26 4.3.3 Ester Derivatives 27 4.3.4 Halo Derivatives 27 4.3.5 Other Androgen Derivatives 28 4.3.6 Summary of Structure–Activity Relationships of Steroidal Androgens 28 4.4 Nonsteroidal Androgens, Selective Androgen Receptor Modulators (SARMs) 30 4.5 Absorption, Distribution, and Metabolism 31 4.6 Toxicities 32 Translational Medicine: Molecular Pharmacology and Drug Discovery First Edition. Edited by Robert A. Meyers. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA. Published 2018 by Wiley-VCH Verlag GmbH & Co. KGaA. 4 Analogs and Antagonists of Male Sex Hormones 5 Anabolic Agents 32 5.1 Current Drugs on the Market 32 5.2 Therapeutic Uses and Bioassays -
A10 Anabolic Steroids Hardcore Info
CONTENTS GENERAL INFORMATION 3 Anabolic steroids – What are they? 4 How do they Work? – Aromatisation 5 More molecules – More problems 6 The side effects of anabolic steroids 7 Women and anabolic steroids 8 Injecting steroids 9 Abscesses – Needle Exchanges 10 Intramuscular injection 11 Injection sites 12 Oral steroids – Cycles – Stacking 13 Diet 14 Where do steroids come from? Spotting a counterfeit 15 Drug Information – Drug dosage STEROIDS 16 Anadrol – Andriol 17 Anavar – Deca-Durabolin 18 Dynabolon – Durabolin – Dianabol 19 Esiclene – Equipoise 20 Primobolan Depot – Proviron – Primobolan orals – Pronobol 21 Sustanon – Stromba, Strombaject – Testosterone Cypionate Testosterone Enanthate 22 Testosterone Propionate – Testosterone Suspension 23 Trenbolone Acetate – Winstrol OTHER DRUGS 24 Aldactone – Arimidex 25 Clenbuterol – Cytomel 26 Ephedrine Hydrochloride – GHB 27 Growth Hormone 28 Insulin 30 Insulin-Like Growth Factor-1 – Human Chorionic Gonadotrophin 31 Tamoxifen – Nubain – Recreational Drugs 32 Steroids and the Law 34 Glossary ANABOLIC STEROIDS People use anabolic steroids for various reasons, some use them to build muscle for their job, others just want to look good and some use them to help them in sport or body building. Whatever the reason, care needs to be taken so that as little harm is done to the body as possible because despite having muscle building effects they also have serious side effects especially when used incorrectly. WHAT ARE THEY? Anabolic steroids are man made versions of the hormone testosterone. Testosterone is the chemical in men responsible for facial hair, deepening of the voice and sex organ development, basically the masculine things Steroids are in a man. used in medicine to treat anaemia, muscle weakness after These masculine effects surgery etc, vascular are called the androgenic disorders and effects of testosterone. -
2010 Prohibited List
The World Anti-Doping Code THE 2010 PROHIBITED LIST INTERNATIONAL STANDARD The official text of the Prohibited List shall be maintained by WADA and shall be published in English and French. In the event of any conflict between the English and French versions, the English version shall prevail. This List shall come into effect on 1 January 2010 The Prohibited List 2010 19 September 2009 THE 2010 PROHIBITED LIST WORLD ANTI-DOPING CODE Valid 1 January 2010 All Prohibited Substances shall be considered as “Specified Substances” except Substances in classes S1, S2.1 to S2.5, S.4.4 and S6.a, and Prohibited Methods M1, M2 and M3. SUBSTANCES AND METHODS PROHIBITED AT ALL TIMES (IN- AND OUT-OF-COMPETITION) PROHIBITED SUBSTANCES S1. ANABOLIC AGENTS Anabolic agents are prohibited. 1. Anabolic Androgenic Steroids (AAS) a. Exogenous* AAS, including: 1-androstendiol (5α-androst-1-ene-3β,17β-diol ); 1-androstendione (5α- androst-1-ene-3,17-dione); bolandiol (19-norandrostenediol); bolasterone; boldenone; boldione (androsta-1,4-diene-3,17-dione); calusterone; clostebol; danazol (17α-ethynyl-17β-hydroxyandrost-4-eno[2,3-d]isoxazole); dehydrochlormethyltestosterone (4-chloro-17β-hydroxy-17α-methylandrosta- 1,4-dien-3-one); desoxymethyltestosterone (17α-methyl-5α-androst-2-en- 17β-ol); drostanolone; ethylestrenol (19-nor-17α-pregn-4-en-17-ol); fluoxymesterone; formebolone; furazabol (17β-hydroxy-17α-methyl-5α- androstano[2,3-c]-furazan); gestrinone; 4-hydroxytestosterone (4,17β- dihydroxyandrost-4-en-3-one); mestanolone; mesterolone; metenolone; methandienone -
Anabolic Steroids/Androgens Pa Summary
ANABOLIC STEROIDS/ANDROGENS PA SUMMARY PREFERRED Anadrol-50, Danazol, Fluoxymesterone, Methitest, Oxandrolone, Testosterone Cypionate Injection, Testosterone Enanthate Injection NON-PREFERRED Android, Testred LENGTH OF AUTHORIZATION: Varies NOTE: All preferred and non-preferred agents require prior authorization. See PA criteria labeled “Topical Testosterone” for Androderm, Androgel, Striant, and Testim. The criteria details below are for the outpatient pharmacy program. If an injectable medication is being administered in a physician’s office then the criteria information below does not apply. Instead, the physician’s office must bill this drug through the DCH physician’s injectable program and not the outpatient pharmacy program. Information regarding the physician’s injectable program can be located at www.mmis.georgia.gov. PA CRITERIA: For Anadrol-50 Approvable for the following diagnoses: anemia caused by deficient red blood cell production, acquired or congenital aplastic anemia, myelofibrosis, hypoplastic anemia due to administration of myelotoxic drugs Also approvable for HIV or AIDS wasting when significant weight loss is documented in members currently receiving nutritional support For Danazol Approvable for the following diagnoses: endometriosis, fibrocystic breast disease, hereditary angioedema For Fluoxymesterone, Methyltestosterone (Android, Methitest, Testred), Testosterone Cypionate or Enanthate Injection Approvable in male members 12 years of age or older for the following diagnoses: primary hypogonadism, secondary -
Presence and Metabolism of Endogenous Androgenic–Anabolic Steroid Hormones in Meat-Producing Animals: a Review J
Food Additives and Contaminants Vol. 26, No. 5, May 2009, 640–671 Presence and metabolism of endogenous androgenic–anabolic steroid hormones in meat-producing animals: a review J. Scartha*, C. Akreb, L. van Ginkelc, B. Le Bizecd, H. De Brabandere, W. Korthf, J. Pointsg, P. Tealea and J. Kayh aHFL Sport Science (a Quotient Bioresearch Company), Fordham, UK; bCanadian Food Inspection Agency, Saskatoon, Canada; cNational Institute of Public Health and the Environment, RIVM, European Union Community Reference Laboratory for Residues, Bilthoven, the Netherlands; dLABERCA, Ecole Nationale Ve´te´rinaire de Nantes, Nantes, France; eFaculty of Veterinary Medicine, Laboratory of Chemical Analysis, Department of Veterinary Public Health and Food Safety, Ghent University, Merelbeke, Belgium; fNational Residue Survey, Australian Government Department of Agriculture, Fisheries and Forestry, Barton, ACT, Australia; gVeterinary Drugs Group, LGC, Teddington, UK; hVeterinary Medicines Directorate, Addlestone, UK (Received 17 April 2008; final version received 15 November 2008) The presence and metabolism of endogenous steroid hormones in meat-producing animals has been the subject of much research over the past 40 years. While significant data are available, no comprehensive review has yet been performed. Species considered in this review are bovine, porcine, ovine, equine, caprine and cervine, while steroid hormones include the androgenic–anabolic steroids testosterone, nandrolone and boldenone, as well as their precursors and metabolites. Information on endogenous steroid hormone concentrations is primarily useful in two ways: (1) in relation to pathological versus ‘normal’ physiology and (2) in relation to the detection of the illegal abuse of these hormones in residue surveillance programmes. Since the major focus of this review is on the detection of steroids abuse in animal production, the information gathered to date is used to guide future research. -
210365Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210365Orig1s000 PROPRIETARY NAME REVIEW(S) Proprietary Name Review Memorandum Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) *** This document contains proprietary information that cannot be released to the public*** Date of This Review: April 19, 2018 Application Type and Number: NDA 210365 Product Name and Strength: Epidiolex (cannabidiol) oral solution 100 mg/mL Product Type: Combination Product Rx or OTC: Rx Applicant/Applicant Name: GW Research Ltd Panorama #: 2018-21548356 DMEPA Deputy Director: Danielle Harris, PharmD, BCPS DMEPA Director: Todd Bridges, RPh Reference ID: 4251176 1. REASON FOR REVIEW The memorandum is written because DMEPA management disagrees with some of Dr. Rider’s position with respect to the acceptability of the proposed proprietary name, Epidiolex for cannabidiol oral solution (NDA 210365), and we describe the points of disagreement below. This memorandum is intended to summarize DMEPA’s overall decision based on our evaluation of Dr. Rider’s review (Panorama # 2018-21548356), and the supporting information submitted in the proposed proprietary name request for reconsideration received March 9, 2018, and the amendment to the request, received March 16, 2018 to NDA 210365. 2. REGULATORY HISTORY The Applicant previously submitted the proposed proprietary name, Epidiolex*** on June 24, 2015 under IND 120055. However, we found the name, Epidiolex*** unacceptable due to 1) orthographic and phonetic similarities with the over-the-counter product name, Pedia-lax and 2) the presence of a USAN stem under IND 120055 on November 10, 2015.a Thus, the Applicant submitted the name, (b) (4) ***, for review on April 4, 2016. -
Jp Xvii the Japanese Pharmacopoeia
JP XVII THE JAPANESE PHARMACOPOEIA SEVENTEENTH EDITION Official from April 1, 2016 English Version THE MINISTRY OF HEALTH, LABOUR AND WELFARE Notice: This English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. The Ministry of Health, Labour and Welfare Ministerial Notification No. 64 Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia (Ministerial Notification No. 65, 2011), which has been established as follows*, shall be applied on April 1, 2016. However, in the case of drugs which are listed in the Pharmacopoeia (hereinafter referred to as ``previ- ous Pharmacopoeia'') [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as ``new Pharmacopoeia'')] and have been approved as of April 1, 2016 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as of March 31, 2016 as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the Same Law (hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017. -
A New Highly Specific and Robust Yeast Androgen Bioassay for the Detection of Agonists and Antagonists
Anal Bioanal Chem (2007) 389:1549–1558 DOI 10.1007/s00216-007-1559-6 ORIGINAL PAPER A new highly specific and robust yeast androgen bioassay for the detection of agonists and antagonists Toine F. H. Bovee & Richard J. R. Helsdingen & Astrid R. M. Hamers & Majorie B. M. van Duursen & Michel W. F. Nielen & Ron L. A. P. Hoogenboom Received: 27 April 2007 /Revised: 3 July 2007 /Accepted: 15 August 2007 / Published online: 12 September 2007 # Springer-Verlag 2007 Abstract Public concern about the presence of natural and very specific and also suited to detect compounds that have anthropogenic compounds which affect human health by an antiandrogenic mode of action. modulating normal endocrine functions is continuously growing. Fast and simple high-throughput screening methods Keywords Antagonists . Brominated flame retardants . for the detection of hormone activities are thus indispens- Crosstalk . Metabolism . Receptor . Saccharomyces able. During the last two decades, a panel of different in vitro cerevisiae assays has been developed, mainly for compounds with an estrogenic mode of action. Here we describe the develop- ment of an androgen transcription activation assay that is Introduction easy to use in routine screening. Recombinant yeast cells were constructed that express the human androgen receptor There is concern that chemicals in our food, water, and and yeast enhanced green fluorescent protein (yEGFP), the environment affect human health by disrupting normal latter in response to androgens. Compared with other endocrine function, possibly leading to reproductive failure reporters, the yEGFP reporter protein is very convenient in humans and tumors in sensitive tissues [1, 2]. This because it is directly measurable in intact living cells, i.e., relates to chemicals with previously unknown hormonal cell wall disruption and the addition of a substrate are not properties, like certain pesticides and plasticizers, but also needed. -
Steroids and Other Appearance and Performance Enhancing Drugs (Apeds) Research Report
Research Report Revised Febrero 2018 Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Table of Contents Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Introduction What are the different types of APEDs? What is the history of anabolic steroid use? Who uses anabolic steroids? Why are anabolic steroids misused? How are anabolic steroids used? What are the side effects of anabolic steroid misuse? How does anabolic steroid misuse affect behavior? What are the risks of anabolic steroid use in teens? How do anabolic steroids work in the brain? Are anabolic steroids addictive? How are anabolic steroids tested in athletes? What can be done to prevent steroid misuse? What treatments are effective for anabolic steroid misuse? Where can I get further information about steroids? References Page 1 Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Esta publicación está disponible para su uso y puede ser reproducida, en su totalidad, sin pedir autorización al NIDA. Se agradece la citación de la fuente, de la siguiente manera: Fuente: Instituto Nacional sobre el Abuso de Drogas; Institutos Nacionales de la Salud; Departamento de Salud y Servicios Humanos de los Estados Unidos. Introduction Appearance and performance enhancing drugs (APEDs) are most often used by males to improve appearance by building muscle mass or to enhance athletic performance. Although they may directly and indirectly have effects on a user’s mood, they do not produce a euphoric high, which makes APEDs distinct from other drugs such as cocaine, heroin, and marijuana. However, users may develop a substance use disorder, defined as continued use despite adverse consequences. -
Ep 2446888 A2
(19) & (11) EP 2 446 888 A2 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 02.05.2012 Bulletin 2012/18 A61K 31/569 (2006.01) (21) Application number: 11010272.0 (22) Date of filing: 12.07.2006 (84) Designated Contracting States: (71) Applicant: DMI Biosciences, Inc. AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Englewood, CO 80110-3948 (US) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR (72) Inventor: Bar-Or, David Designated Extension States: Englewood, Colorado 80110 (US) AL BA HR MK RS (74) Representative: Schaeberle, Steffen (30) Priority: 12.07.2005 US 69872305 P Hoefer & Partner 24.08.2005 US 71115705 P Patentanwälte 24.08.2005 US 71115805 P Pilgersheimer Strasse 20 81543 München (DE) (62) Document number(s) of the earlier application(s) in accordance with Art. 76 EPC: Remarks: 06787393.5 / 1 919 290 This application was filed on 29-12-2011 as a divisional application to the application mentioned under INID code 62. (54) Use of danazol for the treatment of uveitis (57) The present invention relates to the treatment of an inflammatory disease or condition of the eye such as uveitis with danazof or a pharmacologically-acceptable salt or ester thereof. EP 2 446 888 A2 Printed by Jouve, 75001 PARIS (FR) EP 2 446 888 A2 Description FIELD OF THE INVENTION 5 [0001] The present invention relates to the treatment of diseases and conditions with an effective amount of a steroid having those formulas given below, or a pharmacologically-acceptable salt or ester thereof. -
Hirsutism and Polycystic Ovary Syndrome (PCOS)
Hirsutism and Polycystic Ovary Syndrome (PCOS) A Guide for Patients PATIENT INFORMATION SERIES Published by the American Society for Reproductive Medicine under the direction of the Patient Education Committee and the Publications Committee. No portion herein may be reproduced in any form without written permission. This booklet is in no way intended to replace, dictate or fully define evaluation and treatment by a qualified physician. It is intended solely as an aid for patients seeking general information on issues in reproductive medicine. Copyright © 2016 by the American Society for Reproductive Medicine AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE Hirsutism and Polycystic Ovary Syndrome (PCOS) A Guide for Patients Revised 2016 A glossary of italicized words is located at the end of this booklet. INTRODUCTION Hirsutism is the excessive growth of facial or body hair on women. Hirsutism can be seen as coarse, dark hair that may appear on the face, chest, abdomen, back, upper arms, or upper legs. Hirsutism is a symptom of medical disorders associated with the hormones called androgens. Polycystic ovary syndrome (PCOS), in which the ovaries produce excessive amounts of androgens, is the most common cause of hirsutism and may affect up to 10% of women. Hirsutism is very common and often improves with medical management. Prompt medical attention is important because delaying treatment makes the treatment more difficult and may have long-term health consequences. OVERVIEW OF NORMAL HAIR GROWTH Understanding the process of normal hair growth will help you understand hirsutism. Each hair grows from a follicle deep in your skin. As long as these follicles are not completely destroyed, hair will continue to grow even if the shaft, which is the part of the hair that appears above the skin, is plucked or removed. -
Pharmaceutical Appendix to the Tariff Schedule 2
Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. ABACAVIR 136470-78-5 ACIDUM LIDADRONICUM 63132-38-7 ABAFUNGIN 129639-79-8 ACIDUM SALCAPROZICUM 183990-46-7 ABAMECTIN 65195-55-3 ACIDUM SALCLOBUZICUM 387825-03-8 ABANOQUIL 90402-40-7 ACIFRAN 72420-38-3 ABAPERIDONUM 183849-43-6 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABATACEPTUM 332348-12-6 ACITEMATE 101197-99-3 ABCIXIMAB 143653-53-6 ACITRETIN 55079-83-9 ABECARNIL 111841-85-1 ACIVICIN 42228-92-2 ABETIMUSUM 167362-48-3 ACLANTATE 39633-62-0 ABIRATERONE 154229-19-3 ACLARUBICIN 57576-44-0 ABITESARTAN 137882-98-5 ACLATONIUM NAPADISILATE 55077-30-0 ABLUKAST 96566-25-5 ACODAZOLE 79152-85-5 ABRINEURINUM 178535-93-8 ACOLBIFENUM 182167-02-8 ABUNIDAZOLE 91017-58-2 ACONIAZIDE 13410-86-1 ACADESINE 2627-69-2 ACOTIAMIDUM 185106-16-5 ACAMPROSATE 77337-76-9