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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
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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.
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New Zealand Data Sheet 1. Product Name
NEW ZEALAND DATA SHEET 1. PRODUCT NAME SUSTANON 250 (250 mg testosterone esters solution for injection) (SUSTANON) TESTOSTERONE ESTERS 250mg/mL for injection Presentations that are not currently available The vials are currently not available 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substances - testosterone proprionate 30mg testosterone phenylpropionate 60mg testosterone isocaproate 60mg testosterone decanoate 100mg All four compounds are esters of the natural hormone testosterone. The total amount of testosterone per 1 mL is 176mg. List of excipients - 1 mL arachis oil and the solution also contains 10 per cent benzyl alcohol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oily solution for intramuscular use. A clear, pale yellow solution. Each clear glass ampoule or vial contains 1 mL in arachis oil. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Testosterone replacement therapy in males for conditions associated with primary and secondary hypogonadism, either congenital or acquired. In female to male transsexuals: • masculinization Moreover, in men testosterone therapy may be indicated in osteoporosis caused by androgen deficiency. 4.2 Dose and method of administration In general, the dose should be adjusted according to the response of the individual patient. Dose Adults (incl. elderly): Usually, one injection of 1ml per three weeks is adequate. Paediatric population: Safety and efficacy in children and adolescents, have not yet been established. Pre-pubertal children treated with SUSTANON should be treated with caution (see Warnings and Precautions). SUSTANON contains benzyl alcohol and is contraindicatedin children under 3 years of age. Method of administration SUSTANON should be administered by deep intramuscular injection.
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A28 Anabolic Steroids
Anabolic SteroidsSteroids A guide for users & professionals his booklet is designed to provide information about the use of anabolic steroids and some of the other drugs Tthat are used in conjunction with them. We have tried to keep the booklet free from technical jargon but on occasions it has proven necessary to include some medical, chemical or biological terminology. I hope that this will not prevent the information being accessible to all readers. The ﬁrst section explaining how steroids work is the most complex, but it gets easier to understand after that (promise). The booklet is not intended to encourage anyone to use these drugs but provides basic information about how they work, how they are used and the possible consequences of using them. Anabolic Steroids A guide for users & professionals Contents Introduction .........................................................7 Formation of Testosterone ...............................................................8 Method of Action ..............................................................................9 How Steroids Work (illustration).......................................................10 Section 1 How Steroids are Used ....................................... 13 What Steroid? ................................................................................ 14 How Much to Use? ......................................................................... 15 Length of Courses? ........................................................................ 15 How Often to Use Steroids?
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“Detection of Testosterone Esters in Blood Sample” Dr. G. Gmeiner, Dr. G. Forsdahl, Dr. Erceg (Seibersdorf Labor GmbH, Austria) Project Summary Testosterone is still regarded as the major contributor to steroid doping world-wide. Among the most common forms of application are injections of different sorts of esters. State-of-the-Art detection of Testosterone doping includes the quantification of the Testosterone /Epitestosterone – Ratio (T/E – ratio) as well as subsequent Isotope ratio mass spectrometry (IRMS). Previous published studies of our research group have demonstrated that a comparably high percentage of testosterone preparations do not significantly differ from endogenous values of testosterone and markers of testosterone doping. Consequently when such preparations with endogenous – like 13CVPDB values are applied, IRMS - technology fails to detect testosterone doping. Direct detection of the testosterone ester leads to an unequivocal proof of doping with testosterone preparations, because such esters are not built endogenously. Previous studies indicate that a direct detection of testosterone esters in both hair and plasma is possible. Aim of the proposed project is the investigation and optimisation of the direct detection of testosterone esters in body fluids like serum, whole blood and stabilized blood with an already developed detection method using modern and sensitive technology. The project will gain information on diagnostic windows for detection of doping using testosterone esters and proper sampling conditions. Additional aim of the proposed project is to evaluate the suitability of already collected blood samples in doping control (e.g. samples collected for blood parameter measurement or growth hormone detection) for a possible reanalysis for testosterone esters.
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United States Patent (10) Patent No.: US 7,790,910 B2 Macdonald Et Al
US007790910B2 (12) United States Patent (10) Patent No.: US 7,790,910 B2 MacDonald et al. (45) Date of Patent: Sep. 7, 2010 (54) PROCESS FOR THE PREPARATION OF 2003/0069434 A1 4/2003 Bohlmann et al. 7OALKYLATED 19-NORSTEROIDS 2005, OO33085 A1 2/2005 Warren et al. (75) Inventors: Peter Lindsay MacDonald, Gentilino FOREIGN PATENT DOCUMENTS (CH); Ettore Bigatti, Balerna (CH): DE 24, 29 O40 1, 1975 Pierluigi Rossetto, Balerna (CH) DE 19622 457 11, 1997 EP O138504 T 1988 (73) Assignee: Sicor Inc., Irvine, CA (US) WO WO93/10741 6, 1993 WO WO99/33855 * 7/1999 (*) Notice: Subject to any disclaimer, the term of this WO WO99,42109 8, 1999 patent is extended or adjusted under 35 WO WOO2,32922 4/2002 U.S.C. 154(b) by 1427 days. WO WOO3,O31399 4/2003 WO WOO3,O45972 6, 2003 (21) Appl. No.: 11/192,071 WO WO98,07740 T 2003 (22) Filed: Jul. 27, 2005 OTHER PUBLICATIONS Bucourt, et al., “New Biospecific Adsorbents For The Purification Of (65) Prior Publication Data Estradiol Receptor'. Journal of Biological Chemistry, 1978, pp. 8221-8228, vol. 253, No. 22. US 2006/OO30552 A1 Feb. 9, 2006 Dasilva, et al., “Synthesis And Structure-Affinity Of A Series of 7alpha-Undecylestradiol Derivatives: A Potential Vector For Related U.S. Application Data Therapy And Imaging Of Estrogen-Receptor-Positive Cancers'. Journal of Medicinal Chemistry, 1990, pp. 430-434, vol. 33, No. 1. (60) sy, priat e.sfas: A.i Skaddan, et al., “Synthesis And Binding Affinities Of Novel Re s proV1S1ona application o, o s , Ille Containing 7.Alpha.-Substituted Estradiol Complexes: Models For on Aug.
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LEGISLATIVE ASSEMBLY Question on Notice
LEGISLATIVE ASSEMBLY Question On Notice Thursday, 15 February 2018 2560. Ms M. M Quirk to the Minister for Police; I refer to the commencement of operation of the Road Traffic Amendment Act 2016 in March 2017 which introduced compulsory blood or urine samples to be taken from drivers involved in serious crashes, and I ask: (a) since March 2017 how many such samples have been taken; (b) for what specific substances are those blood or urine samples tested; (c) what are the results of those tests to date; and (d) what percentage of drivers have been found to have ingested more than one substance capable of impairing driving skills? Answer (a) The compulsory taking of blood from all drivers involved in serious crashes commenced on 10 March 2017. Between 10 March 2017 and 22 February 2018 (inclusive) a total of 398 blood test samples have been collected under the provision of the Road Traffic Amendment Act 2016. There have been no urine tests collected. (b) Please see attached table for a list of substances in blood sample that are identifiable in ChemCentre toxicology analysis (Paper Number). (c) Of the 398 blood samples collected, 48 are pending results of ChemCentre analysis. Of the 350 analysed, 259 samples had a specific substance(s) detected and 91 samples had no specific substance detected. d) Of the 259 samples with specific substance(s) detected, 92% were found to have multiple substances (more than one). Detectable Substances in Blood Samples capable of identification by the ChemCentre WA. ACETALDEHYDE AMITRIPTYLINE/NORTRIPTYLINE
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WO 2012/148570 Al 1 November 2012 (01.11.2012) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2012/148570 Al 1 November 2012 (01.11.2012) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61L 27/14 (2006.01) A61P 17/02 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, C08L 101/16 (2006.01) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, PCT/US20 12/027464 MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (22) International Filing Date: OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, 2 March 2012 (02.03.2012) SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, 13/093,479 25 April 201 1 (25.04.201 1) US UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant (for all designated States except US): DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, WARSAW ORTHOPEDIC, INC.
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Influence of the Use of Testosterone Associated with Physical
original article Influence of the use of testosterone associated with physical training on some hematologic and physical parameters in older rats with alloxan-induced diabetes Romeu Paulo Martins Silva1,2, Rodrigo Otávio dos Santos2, Nelson Eurípedes Matildes Junior2, Antônio Vicente Mundim3, Mario da Silva Garrote-Filho3, Pâmella Ferreira Rodrigues2, Nilson Penha-Silva3 ABSTRACT 1 Centro de Ciências da Saúde e Objective: This study investigated the possible blood changes in wistar rats elderly with and without Desporto, Universidade Federal do treatment with anabolic steroids submitted physical training. Materials and methods: Elderly rats Acre (UFAC), Rio Branco, AC, Brasil (32) were divided into four groups: normal (N), treated normal (NT), diabetic (D) and treated diabetic 2 Centro Universitário do Planalto de (DT). They were submitted to 20 sessions of swimming with overload (5% body weight), 40 min/ Araxá (Uniaraxá), Araxá, MG, Brasil 3 Instituto de Genética e Bioquímica, day for four weeks. The NT and DT groups received application of testosterone twice a week. At Universidade Federal de Uberlândia the end of the sessions, the animals were subjected to swimming until exhaustion and then killed (UFU), Uberlândia, MG, Brasil for removal of blood and visceral fat. We evaluated maximum swim time, weight of visceral fat, erythrogram, leukogram, lipidogram and serum levels of glucose, lactate, aspartate aminotransferase Correspondence to: and creatine kinase. The results were compared using one-way ANOVA followed by the post hoc Romeu Paulo Martins Silva Tukey test. Results: In elderly diabetic rats, the use of anabolic associated with physical training in Universidade Federal do Acre Instituto de Genética e Bioquímica older rats resulted in improvement in erythrogram, lipidogram and physical performance for high- BR 364, km 04 intensity aerobic exercise.
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(12) Patent Application Publication (10) Pub. No.: US 2005/0101517 A1 De Nijs Et Al
US 2005O1 O1517A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0101517 A1 De Nijs et al. (43) Pub. Date: May 12, 2005 (54) NOVELTESTOSTERONE ESTER (86) PCT No.: PCT/EP01/09569 FORMULATION FOR HUMAN USE (30) Foreign Application Priority Data (76) Inventors: Henrick De Nijs, XC Oss (NL); Wendy Margaretha KerSmaekers, RB Aug. 23, 2000 (EP) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - OO2O2939.5 Nijmegen (NL); Stepanus Cornelis O O Schutte, EJ Oosterbeek (NL); Johann Publication Classification Gerhard Cornelis Van Bruggen, EN 7 Waalwijk (NL) (51) Int. Cl." ..................................................... A61K 31/00 (52) U.S. Cl. .................................................................. 514/1 Correspondence Address: AKZO NOBEL PHARMA PATENT (57) ABSTRACT DEPARTMENT Disclosed is a formulation of testosterone decanoate for use PO BOX 3.18 in the treatment of humans. In contrast with known formu MILLSBORO, DE 19966 (US) lations comprising testosterone decanoate, it was found that any other esters of testosterone normally present together (21) Appl. No.: 10/362,350 with testosterone decanoate, can be omitted and the formu lation thus comprises testosterone decanoate as the Sole ester (22) PCT Filed: Aug. 17, 2001 of testosterone. Patent Application Publication May 12, 2005 US 2005/0101517 A1 Iain?l? US 2005/0101517 A1 May 12, 2005 NOVELTESTOSTERONE ESTER FORMULATION in which the compound is generally included in a broad FOR HUMAN USE range of Summed-up esters of testosterone. In Some patent documents originating from the seventies (BE 855163, U.S. FIELD OF THE INVENTION Pat. No. 4,220,599 (DE 2508615), U.S. Pat. No. 4,071,623) testosterone esters of a chain length typically including 0001) The invention is in the field of the treatment of decanoate are disclosed for oral administration.
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Androgen Deficiency
Androgen Deficiency The GP’s role Diagnosis GPs are generally the first point of contact for men with Medical history symptoms of androgen deficiency. • Undescended testes. GPs are relied upon for clinical and laboratory examinations, • Testicular surgery. appropriate referral, and ongoing patient management. • Pubertal development or virilisation. Patient referral to an endocrinologist, urologist or sexual • Fertility. health specialist is required for PBS-subsidised testosterone prescriptions. • Genitourinary infection. • Coexistent illness (e.g. pituitary disease, thalassaemia, Condition overview haemochromatosis). • Sexual function (all men presenting with erectile dysfunction Androgen deficiency is a syndrome caused by poor testicular should be assessed for androgen deficiency, even though function (hypogonadism), resulting from either primary it is an uncommon cause). (testicular) or secondary (hypothalamic-pituitary) disease, • Drug use (medical or recreational). and is characterised by a low testosterone level accompanied by signs and symptoms1, 2, 3. Clinical examination and assessment It is estimated that approximately 5 in 1000 men have androgen Prepubertal onset 4 deficiency warranting treatment with testosterone . • Micropenis. A low testosterone level alone does not constitute androgen • Small testes. deficiency5, and neither does the normal age-related decline in testosterone (of approximately 1% annually6). Peripubertal onset Androgen deficiency may have subtle effects on health and • Delayed or incomplete sexual and somatic maturation. wellbeing, which can make diagnosis challenging. • Small testes. • Attenuated penile enlargement. Causes • Attenuated pigmentation of scrotum. • Attenuated laryngeal development. Primary hypogonadism • Attenuated growth of facial, body and pubic hair. • Chromosomal (e.g. Klinefelter syndrome (the most common • Poor muscle development. cause of androgen deficiency)). • Gynecomastia. • Undescended testes. • Trauma. Postpubertal onset • Infection (e.g.
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1 Document Title General Guidelines for the Use of Hormone Treatment
General Guidelines For The Use Of Hormone Treatment In Document Title Gender Dysphoria Northern Region Gender Dysphoria Service Dr Helen Greener, Consultant in Gender Dysphoria & Clinical Lead Author Lead Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust Dr Deborah Beere, Consultant in Gender Dysphoria Dr Anna Laws, Clinical Psychologist in Gender Dysphoria Dr Michael Shaw, Consultant in Gender Dysphoria Dr Ewa Wisniewska Young, Consultant in Gender Dysphoria Mary Soulsby, Specialist Nurse in Gender Dysphoria Harrogate District Hospital Contributors Dr Peter Hammond, Consultant Endocrinologist Newcastle upon Tyne Hospitals NHS Foundation Trust Dr Richard Quinton, Consultant Endocrinologist NHS North of England Commissioning Support Unit Helen Seymour, Senior Medicines Optimisation Pharmacist NHS North Tyneside Clinical Commissioning Group Dr Ruth Evans, Medical Director (General Practitioner) Completion date November 2020 Sunderland and South Tyneside Area Prescribing Committee – 3 February 2021 Durham and Tees Valley Area Prescribing Committee – 11 Ratified by March 2021 North of Tyne, Gateshead and North Cumbria Area Prescribing Committee – 13 April 2021 Review Date February 2024 Version number 1 This document supersedes: Guidelines For The Use Of Masculinising Hormone Therapy In Gender Dysphoria: Information for Primary Care November 2014 Guidelines For The Use Of Feminising Hormone Therapy In Gender Dysphoria: Information for Primary Care July 2014 (Minor update November 2014) 1 General Guidelines For The Use Of Hormone
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