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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. -
Adverse Reactions to Hallucinogenic Drugs. 1Rnstttutton National Test
DOCUMENT RESUME ED 034 696 SE 007 743 AUTROP Meyer, Roger E. , Fd. TITLE Adverse Reactions to Hallucinogenic Drugs. 1rNSTTTUTTON National Test. of Mental Health (DHEW), Bethesda, Md. PUB DATP Sep 67 NOTE 118p.; Conference held at the National Institute of Mental Health, Chevy Chase, Maryland, September 29, 1967 AVATLABLE FROM Superintendent of Documents, Government Printing Office, Washington, D. C. 20402 ($1.25). FDPS PRICE FDPS Price MFc0.50 HC Not Available from EDRS. DESCPTPTOPS Conference Reports, *Drug Abuse, Health Education, *Lysergic Acid Diethylamide, *Medical Research, *Mental Health IDENTIFIEPS Hallucinogenic Drugs ABSTPACT This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different methods of therapy. Data are also presented on the psychological and physiolcgical effects of L.S.D. given as a treatment under controlled medical conditions. Possible genetic effects of L.S.D. and other drugs are discussed on the basis of data from laboratory animals and humans. Also discussed are needs for futher research. The necessity to aviod scare techniques in disseminating information about drugs is emphasized. An aprentlix includes seven background papers reprinted from professional journals, and a bibliography of current articles on the possible genetic effects of drugs. (EB) National Clearinghouse for Mental Health Information VA-w. Alb alb !bAm I.S. MOMS Of NAM MON tMAN IONE Of NMI 105 NUNN NU IN WINES UAWAS RCM NIN 01 NUN N ONMININI 01011110 0. -
Neuroreceptor Activation by Vibration-Assisted Tunneling
OPEN Neuroreceptor Activation by SUBJECT AREAS: Vibration-Assisted Tunneling BIOPHYSICAL CHEMISTRY Ross D. Hoehn1, David Nichols2, Hartmut Neven3 & Sabre Kais4,5,6 MECHANISM OF ACTION 1Department of Chemistry, Purdue University, West Lafayette, IN 47907, USA, 2Department of Medicinal Chemistry and Molecular Pharmacology, Purdue University, West Lafayette, IN 47907, USA,3 Google, Venice, CA 90291, USA,4 Department of Received 5 20 October 2014 Chemistry, Purdue University, West Lafayette, IN 47907, USA, Departments of Physics, Purdue University, West Lafayette, IN 47907, USA,6 Qatar Environment and Energy Research Institute, Qatar Foundation, Doha, Qatar. Accepted 20 March 2015 G protein-coupled receptors (GPCRs) constitute a large family of receptor proteins that sense molecular Published signals on the exterior of a cell and activate signal transduction pathways within the cell. Modeling how an 24 April 2015 agonist activates such a receptor is fundamental for an understanding of a wide variety of physiological processes and it is of tremendous value for pharmacology and drug design. Inelastic electron tunneling spectroscopy (IETS) has been proposed as a model for the mechanism by which olfactory GPCRs are activated by a bound agonist. We apply this hyothesis to GPCRs within the mammalian nervous system Correspondence and using quantum chemical modeling. We found that non-endogenous agonists of the serotonin receptor share requests for materials a particular IET spectral aspect both amongst each other and with the serotonin molecule: a peak whose should be addressed to intensity scales with the known agonist potencies. We propose an experiential validation of this model by S.K. (kais@purdue. utilizing lysergic acid dimethylamide (DAM-57), an ergot derivative, and its deuterated isotopologues; we also provide theoretical predictions for comparison to experiment. -
Oral Fluid Drug Test Package Insert
Marijuana (THC) 11-nor-Δ9-THC-9 COOH 4 MTD: Methadone is a synthetic analgesic drug originally used for the Oral Fluid Drug Test treatment of narcotic addiction. In addition to use as a narcotic agonist, methadone is being used more frequently as a pain management agent. The Marijuana (THC) Δ9-THC 50 Package Insert psychological effects induced by using methadone are analgesia, sedation, and respiratory depression. Based on the saliva/plasma ratio calculated over Package insert for testing of the following drugs: > 0.02 % Alcohol (ALC) Alcohol salivary pH ranges of 6.4-7.6 for therapeutic or recreational doses of Amphetamine,Cocaine,Marijuana,Methamphetamine,Opiate,Methadone, B.A.C methadone, a cut-off <50 ng/mL is suggested. Due to this recommendation, Phencyclidine,Oxycodone,Benzodiazepine,Buprenorphine,Barbiturates, the cut-off level of the methadone test was calibrated to 30 ng/mL. Cotinine,EDDP,MDMA,6-MAM,Propoxyphene ,Fentanyl,ETG and Alcohol Tramadol(TRA) 50 Tramadol PCP: Phencyclidine is a hallucinogen and, can be detected in oral fluid as a INTENDED USE & SUMMARY result of the exchange of the drug between the circulatory system and the oral cavity.5 Fentanyl(FEN) 10 The Oral Fluid Drug And Alcohol Test is intended for screening for the Norfentanyl presence of drugs and alcohol and their metabolites in oral fluid. For professional in vitro diagnostic use only. OXY: Oxycodone is a semi-synthetic opioid with a structural similarity to Ethyl codeine. The drug is manufactured by modifying thebaine, an alkaloid found in 150 The Oral Fluid Pipette Test is a lateral flow chromatographic immunoassay for Glucuronide(ETG) the opium poppy. -
Review Memorandum
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k062165 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Qualitative and semi-quantitative enzyme immunoassay E. Applicant: Ortho-Clinical Diagnostics, Inc. F. Proprietary and Established Names: VITROS Chemistry Products BARB Reagent VITROS Chemistry Products Calibrator 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V G. Regulatory Information: 1. Regulation section: 21 CFR 862.3150, Barbiturates test system 21 CFR 862.3200, Clinical Toxicology Calibrator 21 CFR 862.3180, Clinical Toxicology Control 2. Classification: Class II, (reagent, calibrator) Class I, reserved (control) 3. Product code: DIS, DLJ and DIF 4. Panel: Toxicology (91) 1 H. Intended Use: 1. Intended use(s): See Indications for use. 2. Indication(s) for use: VITROS Chemistry Products BARB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi- quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The VITROS Chemistry Products BARB assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result with this assay. Gas Chromatograpy/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. -
Partial Agreement in the Social and Public Health Field
COUNCIL OF EUROPE COMMITTEE OF MINISTERS (PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD) RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies, and superseding Resolution AP (82) 2) AND APPENDIX I Alphabetical list of medicines adopted by the Public Health Committee (Partial Agreement) updated to 1 July 1988 APPENDIX II Pharmaco-therapeutic classification of medicines appearing in the alphabetical list in Appendix I updated to 1 July 1988 RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (superseding Resolution AP (82) 2) (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies) The Representatives on the Committee of Ministers of Belgium, France, the Federal Republic of Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 23 September 1969, 21 April 1988 and 5 May 1964, respectively, Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this -
Molecular Mechanisms of Addiction
Molecular Mechanisms of Addiction Eric J. Nestler Nash Family Professor The Friedman Brain Institute Medical Model of Addiction • Pathophysiology - To identify changes that drugs produce in a vulnerable brain to cause addiction. • Individual Risk - To identify specific genes and non-genetic factors that determine an individual’s risk for (or resistance to) addiction. - About 50% of the risk for addiction is genetic. Only through an improved understanding of the biology of addiction will it be possible to develop better treatments and eventually cures and preventive measures. Scope of Drug Addiction • 25% of the U.S. population has a diagnosis of drug abuse or addiction. • 50% of U.S. high school graduates have tried an illegal drug; use of alcohol and tobacco is more common. • >$400 billion incurred annually in the U.S. by addiction: - Loss of life and productivity - Medical consequences (e.g., AIDS, lung cancer, cirrhosis) - Crime and law enforcement Diverse Chemical Substances Cause Addiction • Opiates (morphine, heroin, oxycontin, vicodin) • Cocaine • Amphetamine and like drugs (methamphetamine, methylphenidate) • MDMA (ecstasy) • PCP (phencyclidine or angel dust; also ketamine) • Marijuana (cannabinoids) • Tobacco (nicotine) • Alcohol (ethanol) • Sedative/hypnotics (barbiturates, benzodiazepines) Chemical Structures of Some Drugs of Abuse Cocaine Morphine Ethanol Nicotine ∆9-tetrahydrocannabinol Drugs of Abuse Use of % of US population as weekly users 100 25 50 75 0 Definition of Drug Addiction • Loss of control over drug use. • Compulsive drug seeking and drug taking despite horrendous adverse consequences. • Increased risk for relapse despite years of abstinence. Definition of Drug Addiction • Tolerance – reduced drug effect after repeated use. • Sensitization – increased drug effect after repeated use. -
September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. ℅ Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 Re: K202567 Trade/Device Name: Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, LCM, QBF, QAW, NFW Dated: September 2, 2020 Received: September 4, 2020 Dear Joe Shia: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. -
Screening of 300 Drugs in Blood Utilizing Second Generation
Forensic Screening of 300 Drugs in Blood Utilizing Exactive Plus High-Resolution Accurate Mass Spectrometer and ExactFinder Software Kristine Van Natta, Marta Kozak, Xiang He Forensic Toxicology use Only Drugs analyzed Compound Compound Compound Atazanavir Efavirenz Pyrilamine Chlorpropamide Haloperidol Tolbutamide 1-(3-Chlorophenyl)piperazine Des(2-hydroxyethyl)opipramol Pentazocine Atenolol EMDP Quinidine Chlorprothixene Hydrocodone Tramadol 10-hydroxycarbazepine Desalkylflurazepam Perimetazine Atropine Ephedrine Quinine Cilazapril Hydromorphone Trazodone 5-(p-Methylphenyl)-5-phenylhydantoin Desipramine Phenacetin Benperidol Escitalopram Quinupramine Cinchonine Hydroquinine Triazolam 6-Acetylcodeine Desmethylcitalopram Phenazone Benzoylecgonine Esmolol Ranitidine Cinnarizine Hydroxychloroquine Trifluoperazine Bepridil Estazolam Reserpine 6-Monoacetylmorphine Desmethylcitalopram Phencyclidine Cisapride HydroxyItraconazole Trifluperidol Betaxolol Ethyl Loflazepate Risperidone 7(2,3dihydroxypropyl)Theophylline Desmethylclozapine Phenylbutazone Clenbuterol Hydroxyzine Triflupromazine Bezafibrate Ethylamphetamine Ritonavir 7-Aminoclonazepam Desmethyldoxepin Pholcodine Clobazam Ibogaine Trihexyphenidyl Biperiden Etifoxine Ropivacaine 7-Aminoflunitrazepam Desmethylmirtazapine Pimozide Clofibrate Imatinib Trimeprazine Bisoprolol Etodolac Rufinamide 9-hydroxy-risperidone Desmethylnefopam Pindolol Clomethiazole Imipramine Trimetazidine Bromazepam Felbamate Secobarbital Clomipramine Indalpine Trimethoprim Acepromazine Desmethyltramadol Pipamperone -
(12) Patent Application Publication (10) Pub. No.: US 2011/0263526 A1 SATYAM (43) Pub
US 20110263526A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0263526 A1 SATYAM (43) Pub. Date: Oct. 27, 2011 (54) NITRICOXIDE RELEASING PRODRUGS OF CD7C 69/96 (2006.01) THERAPEUTICAGENTS C07C 319/22 (2006.01) CD7C 68/02 (2006.01) (75) Inventor: Apparao SATYAM, Mumbai (IN) A6IP 29/00 (2006.01) A6IP 9/00 (2006.01) (73) Assignee: PIRAMAL LIFE SCIENCES A6IP37/08 (2006.01) LIMITED, Mumbai (IN) A6IP35/00 (2006.01) A6IP 25/24 2006.O1 (21) Appl. No.: 13/092.245 A6IP 25/08 308: A6IP3L/04 2006.O1 (22) Filed: Apr. 22, 2011 A6IP3L/2 308: Related U.S. Application Data 39t. O 308: (60) Provisional application No. 61/327,175, filed on Apr. A6IP3/10 (2006.01) 23, 2010. A6IPL/04 (2006.01) A6IP39/06 (2006.01) Publication Classification A6IP3/02 (2006.01) (51) Int. Cl. A6IP 9/06 (2006.01) A 6LX 3L/7072 (2006.01) 39t. W 308: A6 IK3I/58 (2006.01) A6IP II/08 (2006.015 A6 IK3I/55 (2006.01) A63/62 (2006.015 A6 IK 3/495 (2006.01) A6 IK 3/4439 (2006.01) (52) U.S. Cl. ........... 514/50: 514/166; 514/172: 514/217; A6 IK 3L/455 (2006.01) 514/255.04: 514/338; 514/356; 514/412; A6 IK 3/403 (2006.01) 514/420; 514/423: 514/510,536/28.53:540/67; A6 IK 3/404 (2006.01) 540/591; 544/396; 546/273.7: 546/318: 548/452: A6 IK 3/40 (2006.01) 548/500: 548/537; 549/464; 558/275 A6 IK3I/265 (2006.01) C7H 9/06 (2006.01) (57) ABSTRACT CO7I 71/00 (2006.01) CO7D 22.3/26 (2006.01) The present invention relates to nitric oxide releasing pro C07D 295/14 (2006.01) drugs of known drugs or therapeutic agents which are repre CO7D 40/12 (2006.01) sented herein as compounds of formula (I) wherein the drugs CO7D 213/80 (2006.01) or therapeutic agents contain one or more functional groups C07D 209/52 (2006.01) independently selected from a carboxylic acid, an amino, a CO7D 209/26 (2006.01) hydroxyl and a sulfhydryl group. -
Vol. 85 Tuesday, No. 67 April 7, 2020 Pages 19375–19640
Vol. 85 Tuesday, No. 67 April 7, 2020 Pages 19375–19640 OFFICE OF THE FEDERAL REGISTER VerDate Sep 11 2014 21:02 Apr 06, 2020 Jkt 250001 PO 00000 Frm 00001 Fmt 4710 Sfmt 4710 E:\FR\FM\07APWS.LOC 07APWS khammond on DSKJM1Z7X2PROD with FR-1WS II Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 The FEDERAL REGISTER (ISSN 0097–6326) is published daily, SUBSCRIPTIONS AND COPIES Monday through Friday, except official holidays, by the Office PUBLIC of the Federal Register, National Archives and Records Administration, under the Federal Register Act (44 U.S.C. Ch. 15) Subscriptions: and the regulations of the Administrative Committee of the Federal Paper or fiche 202–512–1800 Register (1 CFR Ch. I). The Superintendent of Documents, U.S. Assistance with public subscriptions 202–512–1806 Government Publishing Office, is the exclusive distributor of the official edition. Periodicals postage is paid at Washington, DC. General online information 202–512–1530; 1–888–293–6498 Single copies/back copies: The FEDERAL REGISTER provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 202–512–1800 Federal agencies. These include Presidential proclamations and Assistance with public single copies 1–866–512–1800 Executive Orders, Federal agency documents having general (Toll-Free) applicability and legal effect, documents required to be published FEDERAL AGENCIES by act of Congress, and other Federal agency documents of public Subscriptions: interest. Assistance with Federal agency subscriptions: Documents are on file for public inspection in the Office of the Federal Register the day before they are published, unless the Email [email protected] issuing agency requests earlier filing. -
Clinical and Forensic Toxicology Proficiency Testing (EQA) Catalogue 2011/2012 Contents
Clinical and forensic toxicology proficiency testing (EQA) catalogue 2011/2012 Contents Introduction • Promoting excellence through 3 proficiency testing • Aim of proficiency testing 3 • Quality standards 3 • Benefits of proficiency testing 4 • Who should participate in 4 proficiency testing schemes? • Who participates in LGC Standards 4 proficiency testing schemes? • Why choose LGC Standards as 4 your proficiency testing provider? • Why do I need proficiency testing? 4 • PT/EQA schemes for clinical and 5 forensic toxicology • Benefits of participation in 5 HEATHCONTROL PT/EQA schemes Clinical and forensic PT schemes • HEATHCONTROL – Therapeutic 6 Drug Monitoring (TDM) • HEATHCONTROL – Toxicology (TOX) 8 • HEATHCONTROL – Drugs of Abuse 9 in Urine (DAU) • HEATHCONTROL – Drugs in Oral 10 Fluid (DOF) • QUARTZ – Forensic blood 11 toxicology scheme • FORENSICS PT trial scheme 12 • Confidentiality 13 • Reports 13 • Other PT services 13 • Product development 13 • Reference materials 14 • Summary 14 Tel: +44 (0)161 762 2500 Fax: +44 (0)161 762 2501 Introduction LGC Standards Aim of proficiency testing Promoting excellence through Proficiency testing is defined in ISO/IEC 17043 proficiency testing as the evaluation of participant performance LGC Standards is an accredited international against pre-established criteria by means of provider of proficiency testing (PT) services interlaboratory comparisons. The terms “External also known as External Quality Assessment Quality Assessment or EQA” are often used for (EQA). We have over twenty five years proficiency testing in the medical/clinical area. experience in all aspects of providing PT services LGC Standards Proficiency Testing provides to laboratories undertaking clinical, chemical, a wide range of schemes designed to improve microbiological, and physical measurements.