PORTFOLIO BRAZIL Because We’Requality-Conscious

Total Page:16

File Type:pdf, Size:1020Kb

PORTFOLIO BRAZIL Because We’Requality-Conscious PORTFOLIO BRAZIL YOUR PHARMA API EXPERTS The highest quality, specialized knowledge, and transparency: this is what we bring to active pharmaceutical ingredients. We are your specialists with clearly-defined schedules, extensive high-quality Swiss services, and a global network built up over decades. We focus on a few select therapeutic groups and set the right priorities. Because we’re quality-conscious. US- US- PRODUCT GROUP 4B EDMF PRODUCT GROUP 4B EDMF DMF DMF Abiraterone Acetate Oncology * Gemcitabine Hydrochloride Oncology * CEP Alprazolam Narcotics CEP Hesperidin Vasoprotective PREP Amorolfine HCl Antifungal PREP CEP Hydrocortisone Acetate Corticosteroid CEP Apremilast Immunosupp. * Hydrocortisone Base Corticosteroid Azacitidine Oncology * PREP Levonorgestrel Micro Steroid * Beclomethasone Dipropionate Steroid Methadone HCl Nervous system * CEP Bendamustine HCl Oncology * Methylprednisolone Hormone * CEP Betamethasone Dipropionate Glucocorticoid CEP Mometasone Furoate Steroid CEP Betamethasone Sod. Phosph. Glucocorticoid CEP Morphine Sulfate (Pentahyd.) Narcotics Betamethasone Valerate Glucocorticoid CEP Neostigmine Bromide Nervous system NA CEP Bortezomib Oncology NA Neostigmine Methylsulfate Nervous system NA CEP Calcium Polystyrene Sulph. Cation exch. * Nintedanib Oncology * PREP PREP Carfilzomib Oncology * Noradrenaline Tartrate Cardiovascular * CEP Caspofungin Acetate Antiinfectives NA Opium Raw Analgesic * Cholestyramine Lipid mod. agent PREP PREP PREP Oseltamivir Phosphate Antiinfectives Cinchocaine HCl Nervous system PREP CEP Oxaliplatin Oncology CEP Cisatracurium Besylate Nervous system NA Oxeladine Citrate Antitussive * Clostebol Acetate Steroid * Palbociclib Oncology * PREP PREP Cyproterone Acetate Steroid * CEP Pazopanib Cl Oncology * PREP PREP Dapagliflozin Diabetes NA Pemetrexed Disodium Oncology * Decitabine Oncology NA Pentosan Polysulfate Sodium Anti-inflammatory * Deflazacort Corticosteroid * Prednisolone Acetate Glucocorticoid * CEP Dexamethasone Base Corticosteroid CEP Prednisone Steroid CEP Dexamethasone Sod. Phosp. Corticosteroid CEP Progesterone Hormone * CEP Dexmedetomidine HCl Sedative * Pseudoephedrine HCl Respiratory * CEP Eflornithine HCl Dermatology * Pyridostigmine Bromide Nervous system NA CEP Enzalutamide Endocrine therapy * PREP PREP Ruxolitinib Oncology NA Erlotinib HCl Oncology * PREP PREP Spironolactone Steroid CEP Everolimus Oncology * Tibolone Steroid * CEP Exemestane Oncology * Ticagrelor Antithrombosis * Fluorouracil (5-FU) Oncology * CEP Trifluoperazine Hydrochloride Nervous system Fulverstan Oncology * Vinorelbine Tartrate Oncology * CEP Information Legend Well documented API. All transactions are carried out in conformity with patent Available laws applicable in the user country. Responsibility with respect to third parties * Compilation available upon request patent rights in a specific country lies exclusively with the user. NA not applicable PREP In preparation 4B Stability study zone 4B EDMF Active Substance Master File suitable for submission in the EU US-DMF Drug Master File in CTD format for US-FDA approval DCS Pharma AG • Immengasse 9 • CH-4001 Basel / Switzerland Tel: +41 41 766 04 90 • Fax: +41 41 766 04 99 • [email protected] • www.dcspharma.com 2019-04/KV&CB PORTFOLIO BRAZIL PHARMA API+ Controlled substances Hormones & steroids Muscle relaxants Oncology products Comprehensive services THE DCS PLUS+ FOR API PRODUCERS FOR GENERICS PRODUCERS Take advantage of our We distinguish ourselves through ■ in-depth market know-how ■ top products ■ a worldwide network that we ■ world-class manufacturers developed over decades ■ the right documentation ■ transparent exchange of information ■ a customer support that will exceed your expectations.
Recommended publications
  • 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]
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
    [Show full text]
  • Pharmacy and Poisons Act 1979
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS ACT 1979 1979 : 26 TABLE OF CONTENTS PART I PRELIMINARY 1 Short title 2 Interpretation PART II THE PHARMACY COUNCIL 3 The Pharmacy Council 4 Membership of the Council 4A Functions of the Council 4B Protection from personal liability 4C Annual Report 5 Proceedings of the Council, etc PART III REGISTRATION OF PHARMACISTS 6 Offence to practise pharmacy if not registered 7 Registration as a pharmacist 7A Re-registration as non-practising member 7AA Period of validity of registration 8 Code of Conduct 9 Pharmacy Profession Complaints Committee 10 Investigation of complaint by Committee 10A Inquiry into complaint by Council 10B Inquiry by Council of its own initiative 11 Surrender of registration 12 Restoration of name to register 1 PHARMACY AND POISONS ACT 1979 13 Proof of registration 14 Appeals 14A Fees 14B Amendment of Seventh Schedule 15 Regulations for this part PART IV REGISTRATION OF PHARMACIES 16 Register of pharmacies 17 Registration of premises as registered pharmacies 18 Unfit premises: new applications 19 Unfit premises: registered pharmacies 20 Appeals 21 When certificates of unfitness take effect 22 Regulations for this Part PART V CONTROL OF PRESCRIPTIONS AND IMPORTATION 23 Prescriptions to be in a certain form 23A Validity of a prescription 24 Supply by registered pharmacist of equivalent medicines 25 Restrictions on the importation of medicines 26 Declaration relating to imported medicines [repealed] PART VI CONTROL OF DRUGS 27 Certain substances to be sold on prescription
    [Show full text]
  • University of Groningen Multi-Residue Analysis of Growth Promotors In
    University of Groningen Multi-residue analysis of growth promotors in food-producing animals Koole, Anneke IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 1998 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Koole, A. (1998). Multi-residue analysis of growth promotors in food-producing animals. s.n. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 25-09-2021 APPENDIX 1 OVERVIEW OF RELEVANT SUBSTANCES This appendix consists of two parts. First, substances that are relevant for the research presented in this thesis are given. For each substance CAS number (CAS), molecular weight (MW), bruto formula (formula) and if available UV maxima and alternative names are given. In addition, pKa values for the ß-agonists are listed, if they were available.
    [Show full text]
  • 有限公司 Testosterones
    ® 伊域化學藥業(香港)有限公司 YICK-VIC CHEMICALS & PHARMACEUTICALS (HK) LTD Rm 1006, 10/F, Hewlett Centre, Tel: (852) 25412772 (4 lines) No. 52-54, Hoi Yuen Road, Fax: (852) 25423444 / 25420530 / 21912858 Kwun Tong, E-mail: [email protected] YICK -VIC 伊域 Kowloon, Hong Kong. Site: http://www.yickvic.com Testosterones Product Code CAS Product Name MIS-42658 1043-10-3 (8S,9S,10R,11S,13S,14S,17S)-11,17-DIHYDROXY-10,13,17-TRIMETHYL-2,6,7,8,9,11,12,14,15,16-DECAHYDRO-1H-CYCLOPENTA[A]PHENA NTHREN-3-ONE UNIE-13864 564-35-2 11-KETOTESTOSTERONE PH-1081U 17-ALPHA-HYDROXYTESTOSTERONE ACETATE MIS-39218 51154-09-7 17ALPHA-METHYLTESTOSTERONE 4,5-EPOXIDE PH-1121 72-63-9 17BETA-HYDROXY-17-METHYLANDROSTA-1,4-DIEN-3-ONE MIS-34565 5585-85-3 17BETA-HYDROXY-17-METHYLANDROSTA-4,6-DIEN-3-ONE PH-1081S 17BETA-HYDROXYANDROST-1-ENE-3-ONE TETRAHYDROPYRANYL ETHER PH-1081VA 1-TESTOSTERONE ETHYL CARBONATE PH-1081VB 1-TESTOSTERONE METHYL CARBONATE PH-1081VC 1-TESTOSTERONE PROPYL CARBONATE PH-1081HB 1-TESTOSTERONE UNDECANOATE UNIE-15172 2141-17-5 4-HYDROXYTESTOSTERONE UNIE-13597 62-99-7 6BETA-HYDROXYTESTOSTERONE SPI-4361 14531-84-1 6-DEHYDRO-19-NORTESTOSTERONE PH-1081PK 1057-07-4 ANDROSTANOLONE 17-BENZOATE Copyright © 2018 YICK-VIC CHEMICALS & PHARMACEUTICALS (HK) LTD. All rights reserved. Page 1 of 3 Product Code CAS Product Name PH-1133 1605-89-6 BOLASTERONE UNIE-8525 CHLORDEHYDROMETHYLTESTOSTERONE PH-1081JA 1093-58-9 CLOSTEBOL PH-1081JB 855-19-6 CLOSTEBOL ACETATE SPI-0027GA 481-30-1 EPITESTOSTERONE SPI-0027GB EPITESTOSTERONE ACETATE PH-1081K 434-03-7 ETHISTERONE PH-1136B 76-43-7
    [Show full text]
  • Malta Medicines List April 08
    Defined Daily Doses Pharmacological Dispensing Active Ingredients Trade Name Dosage strength Dosage form ATC Code Comments (WHO) Classification Class Glucobay 50 50mg Alpha Glucosidase Inhibitor - Blood Acarbose Tablet 300mg A10BF01 PoM Glucose Lowering Glucobay 100 100mg Medicine Rantudil® Forte 60mg Capsule hard Anti-inflammatory and Acemetacine 0.12g anti rheumatic, non M01AB11 PoM steroidal Rantudil® Retard 90mg Slow release capsule Carbonic Anhydrase Inhibitor - Acetazolamide Diamox 250mg Tablet 750mg S01EC01 PoM Antiglaucoma Preparation Parasympatho- Powder and solvent for solution for mimetic - Acetylcholine Chloride Miovisin® 10mg/ml Refer to PIL S01EB09 PoM eye irrigation Antiglaucoma Preparation Acetylcysteine 200mg/ml Concentrate for solution for Acetylcysteine 200mg/ml Refer to PIL Antidote PoM Injection injection V03AB23 Zovirax™ Suspension 200mg/5ml Oral suspension Aciclovir Medovir 200 200mg Tablet Virucid 200 Zovirax® 200mg Dispersible film-coated tablets 4g Antiviral J05AB01 PoM Zovirax® 800mg Aciclovir Medovir 800 800mg Tablet Aciclovir Virucid 800 Virucid 400 400mg Tablet Aciclovir Merck 250mg Powder for solution for inj Immunovir® Zovirax® Cream PoM PoM Numark Cold Sore Cream 5% w/w (5g/100g)Cream Refer to PIL Antiviral D06BB03 Vitasorb Cold Sore OTC Cream Medovir PoM Neotigason® 10mg Acitretin Capsule 35mg Retinoid - Antipsoriatic D05BB02 PoM Neotigason® 25mg Acrivastine Benadryl® Allergy Relief 8mg Capsule 24mg Antihistamine R06AX18 OTC Carbomix 81.3%w/w Granules for oral suspension Antidiarrhoeal and Activated Charcoal
    [Show full text]
  • Product Monograph
    PRODUCT MONOGRAPH Sitcom LD Cream Each g contains : Euphorbia Prostrata Extract 1.0% w/w 10 mg (containing 0.315–0.825 mg total flavonoids calculated as apigenin-7-glucoside and 1.26–4.4 mg total phenolics calculated as gallic acid) and Lidocaine 3 % w/w 30 mg cream base. Cream Treatment of Haemorrhoids Manufactured By: Date of Preparation: The Madras Pharmaceuticals (05/07/2019) Old Mahabalipuram Road Karapakkam, Chennai Marketed By: Panacea Biotec Ltd. New Delhi 1 PART I: HEALTH PROFESSIONAL Page No. INFORMATION SUMMARY PRODUCT INFORMATION 4 INDICATIONS AND CLINICAL USE 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5 ADVERSE REACTIONS 7 DRUG INTERACTIONS 8 DOSAGE AND ADMINISTRATION 8 OVERDOSAGE 9 ACTION AND CLINICAL PHARMACOLOGY 9 STORAGE AND STABILITY 9 DOSAGE FORMS, COMPOSITION AND PACKAGING 9 PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION 10 PART III: PATIENT INFORMATION 11 2 Sitcom LD Cream Each g contains : Euphorbia Prostrata Extract 1.0% w/w 10 mg (containing 0.315–0.825 mg total flavonoids calculated as apigenin-7-glucoside and 1.26–4.4 mg total phenolics calculated as gallic acid) and Lidocaine 3 % w/w 30 mg cream base. Cream Treatment of Haemorrhoids 3 PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Dosage Form / Approved Indications Administration Strength Topical Sitcom LD Cream Euphorbia Prostrata is Euphorbia Prostrata indicated for: Extract 1.0% w/w 10 mg (containing 0.315–0.825 - Treatment of Bleeding mg total flavonoids Haemorrhoids calculated as apigenin- - In post- 7-glucoside and 1.26–4.4 haemorrhoidectomy. mg total phenolics calculated as gallic acid) and Lidocaine 3 % w/w 30 mg cream base.
    [Show full text]
  • Pharmaceutical Appendix to the Tariff Schedule 2
    Harmonized Tariff Schedule of the United States (2006) – Supplement 1 (Rev. 1) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2006) – Supplement 1 (Rev. 1) 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. Product CAS No. Product CAS No. ABACAVIR 136470-78-5 ACEXAMIC ACID 57-08-9 ABAFUNGIN 129639-79-8 ACICLOVIR 59277-89-3 ABAMECTIN 65195-55-3 ACIFRAN 72420-38-3 ABANOQUIL 90402-40-7 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABCIXIMAB 143653-53-6 ACITEMATE 101197-99-3 ABECARNIL 111841-85-1 ACITRETIN 55079-83-9 ABIRATERONE 154229-19-3 ACIVICIN 42228-92-2 ABITESARTAN 137882-98-5 ACLANTATE 39633-62-0 ABLUKAST 96566-25-5 ACLARUBICIN 57576-44-0 ABUNIDAZOLE 91017-58-2 ACLATONIUM NAPADISILATE 55077-30-0 ACADESINE 2627-69-2 ACODAZOLE 79152-85-5 ACAMPROSATE 77337-76-9 ACONIAZIDE 13410-86-1 ACAPRAZINE 55485-20-6 ACOXATRINE 748-44-7 ACARBOSE 56180-94-0 ACREOZAST 123548-56-1 ACEBROCHOL 514-50-1 ACRIDOREX 47487-22-9 ACEBURIC
    [Show full text]
  • Download This Issue
    UIP Chapter Meeting - August 25th -27th 2019, Krakow – Poland Contents Foreword 83 UIP Chapter Meeting August 25th -27th 2019, Krakow – Poland 85 Charing Cross International Symposium - Vascular & Endovascular Challenges Update April 15th-18th 2019, London – UK 191 81 Vol 26. No. 3. 2019 Medical Reporters’ Academy The reports from the UIP chapter meeting and Charing cross international symposium were prepared by the following members of the Medical Reporters’ Academy: Roman BREDIKHIN (Russia) Kirill LOBASTOV (Russia) Daniela MASTROIACOVO (Italy) Mustafa SIRLAK (Turkey) Stanislava TZANEVA (Austria) and chaired by: Andrew NICOLAIDES (Cyprus) 82 UIP Chapter Meeting - August 25th -27th 2019, Krakow – Poland Foreword The Medical Reporters’ Academy was co-founded in 1994 as a joint initiative by clinical and research venous disease specialists and Servier; with the main objective to develop an international group of young specialists with a core interest in venous disease drawn from various fields including dermatology, vascular surgery, angiology and/or phlebology. Each year the Medical Reporters’ Academy members are invited by Servier, to cover one of the most important international congresses for venous disease specialists. This year, the UIP Chapter Meeting, which was held in Krakow, Poland on August 25th- 27th, 2019 and the Charing Cross International Symposium: Vascular & Endovascular Challenges Update which was held in London, United Kingdom on April 15th - 18th, 2019 were selected because these congresses involved renowned international and national venous experts and young health care professionals providing a great opportunity to exchange ideas, explore strategies for vein care and discuss the latest trends & innovations in the field. Together with Andrew Nicolaides, the chairman of the group, the academy members explored the program of the congress, selected the events and presentations likely to present breakthroughs or new findings to attend, and wrote short reports.
    [Show full text]
  • Mucoadhesive Drug Delivery Devices and Methods Of
    (19) TZZ___T (11) EP 1 691 746 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61F 13/00 (2006.01) A61K 9/00 (2006.01) 27.05.2015 Bulletin 2015/22 A61K 9/16 (2006.01) A61K 38/38 (2006.01) A61K 47/10 (2006.01) (21) Application number: 04813308.6 (86) International application number: (22) Date of filing: 08.12.2004 PCT/US2004/040975 (87) International publication number: WO 2005/055945 (23.06.2005 Gazette 2005/25) (54) MUCOADHESIVE DRUG DELIVERY DEVICES AND METHODS OF MAKING AND USING THEREOF MUKOADHÄSIVE ARZNEIMITTELABGABEVORRICHTUNGEN UND VERFAHREN ZU IHRER HERSTELLUNG UND VERWENDUNG DISPOSITIFS D’ADMINISTRATION DE MEDICAMENTS MUCOADHESIFS ET PROCEDES DE FABRICATION ET D’UTILISATION ASSOCIES (84) Designated Contracting States: • BERG, Eric, P. AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Plymouth, MN 55447 (US) HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR (74) Representative: Robertson, James Alexander et al (30) Priority: 08.12.2003 US 527962 P Marks & Clerk LLP 90 Long Acre (43) Date of publication of application: London WC2E 9RA (GB) 23.08.2006 Bulletin 2006/34 (56) References cited: (73) Proprietor: Gel-Del Technologies, Inc. WO-A1-01/28524 WO-A1-99/32107 St. Paul, MN 55114 (US) WO-A1-02/058735 US-A- 5 385 606 US-A- 5 863 554 US-A1- 2002 141 945 (72) Inventors: US-A1- 2003 215 515 • MASTERS, David, B. Hastings, MN 55033 (US) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations.
    [Show full text]
  • 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.
    [Show full text]
  • DATA SUPPLEMENT Safety and Efficacy of Combination Nivolumab
    DATA SUPPLEMENT Safety and Efficacy of Combination Nivolumab Plus Ipilimumab in Patients with Advanced Melanoma: Results from a North American Expanded Access Program (CheckMate 218) F. Stephen Hodi, Paul B. Chapman, Mario Sznol, Christopher D. Lao, Rene Gonzalez, Michael Smylie, Gregory A. Daniels, John A. Thompson, Ragini Kudchadkar, William Sharfman, Michael Atkins, David R. Spigel, Anna Pavlick, Jose Monzon, Kevin B. Kim, Scott Ernst, Nikhil I. Khushalani, Wim van Dijck, Maurice Lobo, David Hogg 1 Supplementary Tables Table S1: Summary of adverse events reported between first dose and 30 days after last dose of the EAP therapy that required immune modulating medications in ≥1% of patients Nivolumab plus ipilimumab (N=754) Any grade, Grade 3–4, N (%)a N (%) Any adverse event 600 (80) 332 (44) Diarrhea 132 (18) 52 (7) Maculopapular rash 115 (15) 22 (3) Colitis 76 (10) 57 (8) Increased alanine aminotransferase 72 (10) 47 (6) Increased aspartate aminotransferase 58 (8) 32 (4) Rash 52 (7) 3 (<1) Pruritus 47 (6) 3 (<1) Pneumonitis 39 (5) 9 (1) Hypophysitis 38 (5) 5 (1) Autoimmune hepatitis 37 (5) 28 (4) Pruritic rash 29 (4) 0 Generalized pruritus 22 (3) 3 (<1) Nausea 20 (3) 5 (1) Adrenal insufficiency 18 (2) 3 (<1) Generalized rash 15 (2) 5 (1) Fatigue 14 (2) 3 (<1) Malignant neoplasm progression 12 (2) 11 (1) Arthralgia 12 (2) 2 (<1) Vomiting 12 (2) 2 (<1) Uveitis 11 (1) 1 (<1) Headache 11 (1) 1 (<1) increased transaminases 11 (1) 8 (1) Macular rash 11 (1) 2 (<1) Pyrexia 10 (1) 1 (<1) Increased lipase 10 (1) 9 (1) Acute kidney injury 9 (1) 6 (1) Hepatitis 9 (1) 6 (1) Cough 9 (1) 0 Acneiform dermatitis 9 (1) 0 Abdominal pain 8 (1) 2 (<1) aOne grade 5 adverse event (due to malignant neoplasm progression) was reported.
    [Show full text]