2010 Prohibited List
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5 Part 1300—Definitions
PART 1300—DEFINITIONS (7) 5-androstenediol (3b,17b-dihydroxy- androst-5-ene) Sec. (8) 1-androstenedione ([5a]-androst-1- 1300.01 Definitions relating to controlled en-3,17-dione) substances. (9) 4-androstenedione (androst-4-en- 1300.02 Definitions relating to listed chemi- 3,17-dione) cals. (10) 5-androstenedione (androst-5-en- 1300.03 Definitions relating to electronic or- 3,17-dione) ders for controlled substances and elec- tronic prescriptions for controlled sub- (11) bolasterone (7a,17a-dimethyl-17b- stances. hydroxyandrost-4-en-3-one) 1300.04 Definitions relating to the dis- (12) boldenone (17b-hydroxyandrost-1,4- pensing of controlled substances by diene-3-one) means of the Internet. (13) boldione (androsta-1,4-diene-3,17- 1300.05 Definitions relating to the disposal dione) of controlled substances. (14) calusterone (7b,17a-dimethyl-17b- AUTHORITY: 21 U.S.C. 802, 821, 822, 829, hydroxyandrost-4-en-3-one) 871(b), 951, 958(f). (15) clostebol (4-chloro-17b- SOURCE: 62 FR 13941, Mar. 24, 1997, unless hydroxyandrost-4-en-3-one) otherwise noted. (16) dehydrochloromethyltestosterone (4-chloro-17b-hydroxy-17a-methyl- § 1300.01 Definitions relating to con- androst-1,4-dien-3-one) trolled substances. (17) desoxymethyltestosterone (17a- (a) Any term not defined in this part methyl-5a-androst-2-en-17b-ol) shall have the definition set forth in (a.k.a. ‘madol‘) section 102 of the Act (21 U.S.C. 802), (18) D1-dihydrotestosterone (a.k.a.‘1- except that certain terms used in part testosterone‘) (17b-hydroxy-5a- 1316 of this chapter are defined at the androst-1-en-3-one) beginning of each subpart of that part. -
Anabolic-Androgenic Steroids in Horses: Natural Presence and Underlying Biomechanisms
ANABOLIC-ANDROGENIC STEROIDS IN HORSES: NATURAL PRESENCE AND UNDERLYING BIOMECHANISMS Anneleen Decloedt Dissertation submitted in the fulfilment of the requirements for the degree of Doctor of philosophy (PhD) in Veterinary Sciences, Faculty of Veterinary Medicine, Ghent University PROMOTER Prof. dr. ir. Lynn Vanhaecke Ghent University, Faculty of Veterinary Medicine Department of Veterinary Public Health and Food Safety Laboratory of Chemical Analysis MEMBERS OF THE READING COMMITTEE Prof. dr. James Scarth HFL Sport Science, Cambridgeshire, United-Kingdom Prof. dr. Peter Van Eenoo Ghent University, DoCoLab, Zwijnaarde, Belgium Prof. dr. Ann Van Soom Ghent University, Faculty of Veterinary Medicine, Merelbeke, Belgium MEMBERS OF THE EXAMINATION COMMITTEE Dr. Ludovic Bailly-Chouriberry Laboratoires des Courses Hippiques, Verrières-le-Buisson, France Dr. Leen Van Ginkel Wageningen University, RIKILT, Wageningen, The Netherlands Prof. dr. Myriam Hesta Ghent University, Faculty of Veterinary Medicine, Merelbeke, Belgium This work was funded by the Fédération Nationale des Courses Françaises (via the Laboratoire des Courses Hippiques) and executed at the Laboratory of Chemical Analysis (Faculty of Veterinary Medicine, Ghent University, Merelbeke). The author and the promoter give the authorisation to consult and to copy parts of this work for personal use only. Every other use is subject to the copyright laws. Permission to reproduce any material contained in this work should be obtained from the author. “The universe is full of magic, Just patiently waiting for our wits to grow sharper” TABLE OF CONTENTS TABLE OF CONTENTS Chapter I – General Introduction 1 1. Steroids 3 1.1 Chemical structure 1.2 (Steroid) hormones and their role in the endocrine system 1.3 Biosynthesis of steroid hormones 1.4 Anabolic-androgenic steroids (AAS) 1.5 Synthesis and absorption of the steroid precursor cholesterol 2. -
Properties and Units in Clinical Pharmacology and Toxicology
Pure Appl. Chem., Vol. 72, No. 3, pp. 479–552, 2000. © 2000 IUPAC INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE SCIENTIFIC DIVISION COMMITTEE ON NOMENCLATURE, PROPERTIES, AND UNITS (C-NPU)# and INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY CHEMISTRY AND HUMAN HEALTH DIVISION CLINICAL CHEMISTRY SECTION COMMISSION ON NOMENCLATURE, PROPERTIES, AND UNITS (C-NPU)§ PROPERTIES AND UNITS IN THE CLINICAL LABORATORY SCIENCES PART XII. PROPERTIES AND UNITS IN CLINICAL PHARMACOLOGY AND TOXICOLOGY (Technical Report) (IFCC–IUPAC 1999) Prepared for publication by HENRIK OLESEN1, DAVID COWAN2, RAFAEL DE LA TORRE3 , IVAN BRUUNSHUUS1, MORTEN ROHDE1, and DESMOND KENNY4 1Office of Laboratory Informatics, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark; 2Drug Control Centre, London University, King’s College, London, UK; 3IMIM, Dr. Aiguader 80, Barcelona, Spain; 4Dept. of Clinical Biochemistry, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland #§The combined Memberships of the Committee and the Commission (C-NPU) during the preparation of this report (1994–1996) were as follows: Chairman: H. Olesen (Denmark, 1989–1995); D. Kenny (Ireland, 1996); Members: X. Fuentes-Arderiu (Spain, 1991–1997); J. G. Hill (Canada, 1987–1997); D. Kenny (Ireland, 1994–1997); H. Olesen (Denmark, 1985–1995); P. L. Storring (UK, 1989–1995); P. Soares de Araujo (Brazil, 1994–1997); R. Dybkær (Denmark, 1996–1997); C. McDonald (USA, 1996–1997). Please forward comments to: H. Olesen, Office of Laboratory Informatics 76-6-1, Copenhagen University Hospital (Rigshospitalet), 9 Blegdamsvej, DK-2100 Copenhagen, Denmark. E-mail: [email protected] Republication or reproduction of this report or its storage and/or dissemination by electronic means is permitted without the need for formal IUPAC permission on condition that an acknowledgment, with full reference to the source, along with use of the copyright symbol ©, the name IUPAC, and the year of publication, are prominently visible. -
Us Anti-Doping Agency
2019U.S. ANTI-DOPING AGENCY WALLET CARDEXAMPLES OF PROHIBITED AND PERMITTED SUBSTANCES AND METHODS Effective Jan. 1 – Dec. 31, 2019 CATEGORIES OF SUBSTANCES PROHIBITED AT ALL TIMES (IN AND OUT-OF-COMPETITION) • Non-Approved Substances: investigational drugs and pharmaceuticals with no approval by a governmental regulatory health authority for human therapeutic use. • Anabolic Agents: androstenediol, androstenedione, bolasterone, boldenone, clenbuterol, danazol, desoxymethyltestosterone (madol), dehydrochlormethyltestosterone (DHCMT), Prasterone (dehydroepiandrosterone, DHEA , Intrarosa) and its prohormones, drostanolone, epitestosterone, methasterone, methyl-1-testosterone, methyltestosterone (Covaryx, EEMT, Est Estrogens-methyltest DS, Methitest), nandrolone, oxandrolone, prostanozol, Selective Androgen Receptor Modulators (enobosarm, (ostarine, MK-2866), andarine, LGD-4033, RAD-140). stanozolol, testosterone and its metabolites or isomers (Androgel), THG, tibolone, trenbolone, zeranol, zilpaterol, and similar substances. • Beta-2 Agonists: All selective and non-selective beta-2 agonists, including all optical isomers, are prohibited. Most inhaled beta-2 agonists are prohibited, including arformoterol (Brovana), fenoterol, higenamine (norcoclaurine, Tinospora crispa), indacaterol (Arcapta), levalbuterol (Xopenex), metaproternol (Alupent), orciprenaline, olodaterol (Striverdi), pirbuterol (Maxair), terbutaline (Brethaire), vilanterol (Breo). The only exceptions are albuterol, formoterol, and salmeterol by a metered-dose inhaler when used -
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. -
CHEQUE® DROPS CII Pharmacia & Upjohn Estrous Preventive Mibolerone Drops NADA No.: 102-709 Active Ingredient(S): Each Ml Co
CHEQUE® DROPS CII Pharmacia & Upjohn Estrous Preventive Mibolerone drops NADA No.: 102-709 Active Ingredient(s): Each mL contains 100 mcg mibolerone and propylene glycol, qs. Indications: CHEQUE® (mibolerone) Drops are administered orally for estrous (heat) prevention in adult female dogs not intended primarily for breeding purposes. CHEQUE® Drops dosage should be discontinued after 24 months of use. CHEQUE® Drops are effective in preventing estrus only when drug administration is initiated 30 days prior to the start of the proestrus. It should not be used in an attempt to abbreviate an estrous period. It should not be used in bitches prior to the first estrous period. Pharmacology: CHEQUE® (mibolerone) Drops are 17-b-hydroxy-7a, 17-dimethyl-estr-4-en-3-one, generic name mibolerone, a non-progestational steroid. In its pure form, mibolerone is a white crystalline solid. The compound is stable under ordinary conditions and temperatures. Actions: More than 90 percent of normal, mature cycling bitches did not exhibit estrus when administered CHEQUE® (mibolerone) Drops in adequate doses. Mibolerone has been shown to be an anabolic and androgenic steroid in rats. When compared to methyltestosterone, it is 41 times more potent as an anabolic agent and 16 times more potent as an androgen. Mibolerone has no estrogenic activity in mice when used at levels up to 1.0 mg per animal per day. It is antiestrogenic in mice in intravaginal tests at 0.9 mcg and in subcutaneous tests at 10 mcg or less when tested against estradiol. In the bitch, mibolerone has androgenic, anabolic and antigonadotrophic activity. -
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. -
Prohibited List
PROHIBITED LIST This List shall come into effect on 1 January 201X THE 201X PROHIBITED LIST Valid 1 January 201X In accordance with ARCI-011-015/ARCI-025-015 all substances in the categories below shall be strictly prohibited unless otherwise noted. Any reference to substances in this section does not alter the requirements for testing concentrations in race day samples. SUBSTANCES AND METHODS PROHIBITED AT ALL TIMES (IN- AND OUT-OF-COMPETITION) PROHIBITED SUBSTANCES Nothing in this list shall alter the requirements of post-race testing. S0. NON-APPROVED SUBSTANCES Any pharmacologic substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human or veterinary use (e.g., drugs under pre-clinical or clinical development, discontinued drugs, and designer drugs) is prohibited at all times. S00. THERAPEUTIC SUBSTANCES Therapeutic substances that are not otherwise prohibited pursuant to this list are permitted provided such substances: Have current approval for use in human, horse, or other animal by any governmental regulatory health authority in the jurisdiction where the horse is located S1. ANABOLIC AGENTS Anabolic agents are prohibited. 1. Anabolic Androgenic Steroids (AAS) 1.1. Exogenous* AAS, including: 1-androstenediol (5α-androst-1-ene-3β,17β-diol ); 1-androstenedione (5α- androst-1-ene-3,17-dione); bolandiol (estr-4-ene-3β,17β-diol ); bolasterone; boldenone; boldione (androsta-1,4-diene-3,17-dione); calusterone; clostebol; danazol -
Misuse of Drugs (Miscellaneous Amendments) (No. 2) (Jersey) Order 2012 Arrangement
Misuse of Drugs (Miscellaneous Amendments) (No. 2) (Jersey) Order 2012 Arrangement MISUSE OF DRUGS (MISCELLANEOUS AMENDMENTS) (No. 2) (JERSEY) ORDER 2012 Arrangement Article 1 Schedule 2 to the Misuse of Drugs (Jersey) Law 1978 amended .................... 3 2 Schedule to the Misuse of Drugs (Designation) (Jersey) Order 1989 amended .......................................................................................................... 9 3 Misuse of Drugs (General Provisions) (Jersey) Order 2009 amended .......... 11 4 Citation and commencement ......................................................................... 18 ◊ Page - 1 Misuse of Drugs (Miscellaneous Amendments) (No. 2) (Jersey) Order 2012 Article 1 MISUSE OF DRUGS (MISCELLANEOUS AMENDMENTS) (No. 2) (JERSEY) ORDER 2012 Made Coming into force THE MINISTER FOR HEALTH AND SOCIAL SERVICES, in pursuance of Articles 3, 4, 5, 8, 12, 13 and 27 of the Misuse of Drugs (Jersey) Law 1978, and after consultation with the Advisory Council on the Misuse of Drugs, orders as follows – 1 Schedule 2 to the Misuse of Drugs (Jersey) Law 1978 amended (1) In this Article “Law” means the Misuse of Drugs (Jersey) Law 1978. (2) In Part 1 of Schedule 2 to the Law, in paragraph 1(a), after the entry “Sufentanil” there shall be inserted the following entry – “Tapentadol”. (3) In Part 2 of Schedule 2 to the Law – (a) in paragraph 1(a) after the entry “Methylphenobarbitone” there shall be inserted the entry – “Nabilone”; (b) for the full stop at the end of paragraph 1(i) there shall be substituted a semi-colon; and (c) after paragraph 1(i) there shall be added the following sub- paragraphs – “(j) the following substances – 6-(2-aminopropyl)benzofuran 5-(2-aminopropyl)benzofuran; (k) Any compound (not being pipradrol) structurally derived from piperidine, pyrrolidine, azepane, morpholine or pyridine by substitution at a ring carbon atom with a diphenylmethyl group, whether or not the compound is further modified in any of the following ways, that is to say – ◊ Page - 3 Misuse of Drugs (Miscellaneous Amendments) (No. -
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 -
Control Be Implemented. the First Large-Scale Systematic Olympic Games
Br J Sports Med: first published as 10.1136/bjsm.11.4.162 on 1 December 1977. Downloaded from 162 Brit. J. Sports Med. - Vol. 1 1, No. 4, December 1977, pp. 162-169 RADIOIMMUNOASSAY OF ANABOLIC STEROIDS: AN EVALUATION OF THREE ANTISERA FOR THE DETECTION OF ANABOLIC STEROIDS IN BIOLOGICAL FLUIDS Robert DUGAL, Ph.D., Claire DUPUIS, Ph.D. and Michel J. BERTRAND, Ph.D. Centre de Recherches en Sciences de la Sante, Institut National de la Recherche Scientifique, Centre Hospitalier Louis-H. Lafontaine, Montrdal, Quebec, Canada ABSTRACT Recently developped radioimmunoassays (RIA) for the analysis of anabolic steroids and their metabolites in biological fluids were tested for cross-reactivity with other types of steroids. Results show that the degree of desirable cross-reactivity within the two classes of orally active anabolic steroids vary widely and that the antiserum for 19-Nortestosterone (the active principle of intramuscular, preparations) has a very high degree of undesirable cross- reactivity with components of oral contraceptives. Single and multiple dose studies in human volunteers demonstrate that the detection level and degree of retrospectivity are likewise variable but that the test easily detects most anabolic steroids during treatment. At the present time, the combination of the three antisera for the assay of a sample appears to be a relatively rapid and economic method for screening large numbers of samples in situations where doping control of anabolic steroids is required. The importance of utilizing physico-chemical means for identification of RIA potential positives is emphasized. INTRODUCTION (Sumner, 1974: Brooks et al, 1975) and identification procedures for a limited number of them have also been copyright. -
Multi-Discipline Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212099Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA 212099 Multi-disciplinary Review and Evaluation Darolutamide/NUBEQA NDA/BLA Multi-Disciplinary Review and Evaluation Application Type NDA Application Number(s) 212099 Priority or Standard Priority Submit Date(s) February 26, 2019 Received Date(s) February 26. 2019 PDUFA Goal Date August 26, 2019 Division/Office Division of Oncology Products 1/Office of Hematology & Oncology Products Review Completion Date Established/Proper Name Darolutamide (Proposed) Trade Name Nubeqa Pharmacologic Class Androgen receptor inhibitor Code name 427492003 | Hormone refractory prostate cancer (disorder) Applicant Bayer Doseage form 300 mg tablets Applicant proposed Dosing NUBEQA 600 mg, (two 300 mg tablets) administered orally Regimen twice daily. Swallow tablets whole. Take NUBEQA with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Applicant Proposed NUBEQA is an androgen receptor inhibitor indicated for the Indication(s)/Population(s) treatment of patients with non-metastatic castration-resistant prostate cancer. Applicant Proposed Non-metastatic castration resistant prostate cancer (nmCRPC) SNOMED CT Indication Disease Term for each Proposed Indication Recommendation on Regular approval Regulatory Action Recommended