Food and Drugs Act 2005
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Lipid-Based Depots: Manufacturing, Administration and Interactions of Protein Drugs with Lipid Formulations
Dissertation zur Erlangung des Doktorgrades der Fakultät für Chemie und Pharmazie der Ludwig-Maximilians-Universität München Lipid-based depots: manufacturing, administration and interactions of protein drugs with lipid formulations Michaela Maria Breitsamer aus Starnberg, Deutschland 2019 II ERKLÄRUNG Diese Dissertation wurde im Sinne von § 7 der Promotionsordnung vom 28. November 2011 von Herrn Prof. Dr. Gerhard Winter betreut. EIDESSTATTLICHE VERSICHERUNG Diese Dissertation wurde eigenständig und ohne unerlaubte Hilfe erarbeitet. Wolfratshausen, den 20.05.2019 ________________________________ (Michaela Breitsamer) Dissertation eingereicht am: 20.05.2019 1. Gutachter: Prof. Dr. Gerhard Winter 2. Gutachter: Prof. Dr. Wolfgang Frieß Mündliche Prüfung am: 25.06.2019 III IV FOR MY FAMILY “The way to get started is to quit talking and begin doing” Walt Disney (1901 – 1966) V VI ACKNOWLEDGEMENTS The present thesis was prepared between March 2015 and December 2018 at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics at the Ludwig-Maximilians Universität (LMU) in Munich under the supervision of Prof. Dr. Gerhard Winter. First of all, I would like to express my deepest gratitude to my supervisor Prof. Dr. Gerhard Winter for giving me the opportunity to join his research group and to work on this extremely interesting and interdisciplinary project. I really appreciated his scientific input throughout all phases of this work, his elaborate advice and his guidance, which also contributed to my personal development over the last years. Furthermore, I would like to thank him for the outstanding working and team atmosphere, which he created at the chair, for supporting my participation in scientific conferences and for initiating and motivating me to the numerous collaborations which contributed to a successful thesis. -
Food and Drugs Regulations
LAWS OF TRINIDAD AND TOBAGO 22 Chap. 30:01 Food and Drugs SUBSIDIARY LEGISLATION FOOD AND DRUGS REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION 1. Citation. 2. Requirements prescribed by regulation. 3. Interpretation. 4. Request to Director. 5. Functions, duties, responsibilities of Inspectors. 6. Certificate of appointment. 7. Taking of photographs. 8. Taking samples and detention pending further examination. 9. Violation of Act or Regulations and relabelling or recondition ing of food, drug, cosmetic or device. 10. Issue of certificate. 11. Taking a sample, notification of intention and division of sample. 12. Division an interference and objection to procedure by owner or person. 13. Certificate of Analysis. 14. Definition of terms in Part II. 15. Offence to sell unlabelled food. 16. Labelling of package. 17. Declaration of net contents not required on certain labels. 18. List of ingredients not required on certain labels. 19. Declaration not required. 20. Declaration not required to indicate presence of flavouring. 21. Dried or dehydrated products. 22. Food from vending machine. 23. Non application of regulation 16. 24. Standard for a food. 25. Name of designation given to standard, grade or definition. 26. Adulteration of food. 27. Non-adulteration. 28. Contents of package. 29. Display of information on label. 30. First Schedule. 31. Offence. 32. Definition of terms in Part III. 33. Labelling of drug. 34. Contents of label. 35. Label on bulk package. 36. Drug sold on prescription. 37. Packing cases. LAWS OF TRINIDAD AND TOBAGO Food and Drugs Chap. 30:01 23 Food and Drugs Regulations [Subsidiary} REGULATION 38. Name and proportion of drug to be stated on label. -
Addictions and the Brain
9/18/2012 Addictions and the Brain TAAP Conference September 14, 2012 Acknowledgements • La Hacienda Treatment Center • American Society of Addiction Medicine • National Institute of Drug Abuse © 2012 La Hacienda Treatment Center. All rights reserved. 1 9/18/2012 Definition • A primary, progressive biochemical, psychosocial, genetically transmitted chronic disease of relapse who’s hallmarks are denial, loss of control and unmanageability. DSM IV Criteria for dependency: At least 3 of the 7 below 1. Withdrawal 2. Tolerance 3. The substance is taken in larger amounts or over a longer period than was intended. 4. There is a persistent desire or unsuccessful efforts to cut down or control substance use. 5. A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects. 6. Important social, occupational, or recreational activities are given up or reduced because of the substance use. 7. The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance. © 2012 La Hacienda Treatment Center. All rights reserved. 2 9/18/2012 Dispute between behavior and disease Present understanding of the Hypothalamus location of the disease hypothesis. © 2012 La Hacienda Treatment Center. All rights reserved. 3 9/18/2012 © 2012 La Hacienda Treatment Center. All rights reserved. 4 9/18/2012 © 2012 La Hacienda Treatment Center. All rights reserved. 5 9/18/2012 Dispute regarding behavior versus disease © 2012 La Hacienda Treatment Center. All rights reserved. 6 9/18/2012 © 2012 La Hacienda Treatment Center. -
FSI-D-16-00226R1 Title
Elsevier Editorial System(tm) for Forensic Science International Manuscript Draft Manuscript Number: FSI-D-16-00226R1 Title: An overview of Emerging and New Psychoactive Substances in the United Kingdom Article Type: Review Article Keywords: New Psychoactive Substances Psychostimulants Lefetamine Hallucinogens LSD Derivatives Benzodiazepines Corresponding Author: Prof. Simon Gibbons, Corresponding Author's Institution: UCL School of Pharmacy First Author: Simon Gibbons Order of Authors: Simon Gibbons; Shruti Beharry Abstract: The purpose of this review is to identify emerging or new psychoactive substances (NPS) by undertaking an online survey of the UK NPS market and to gather any data from online drug fora and published literature. Drugs from four main classes of NPS were identified: psychostimulants, dissociative anaesthetics, hallucinogens (phenylalkylamine-based and lysergamide-based materials) and finally benzodiazepines. For inclusion in the review the 'user reviews' on drugs fora were selected based on whether or not the particular NPS of interest was used alone or in combination. NPS that were use alone were considered. Each of the classes contained drugs that are modelled on existing illegal materials and are now covered by the UK New Psychoactive Substances Bill in 2016. Suggested Reviewers: Title Page (with authors and addresses) An overview of Emerging and New Psychoactive Substances in the United Kingdom Shruti Beharry and Simon Gibbons1 Research Department of Pharmaceutical and Biological Chemistry UCL School of Pharmacy -
Upregulation of Peroxisome Proliferator-Activated Receptor-Α And
Upregulation of peroxisome proliferator-activated receptor-α and the lipid metabolism pathway promotes carcinogenesis of ampullary cancer Chih-Yang Wang, Ying-Jui Chao, Yi-Ling Chen, Tzu-Wen Wang, Nam Nhut Phan, Hui-Ping Hsu, Yan-Shen Shan, Ming-Derg Lai 1 Supplementary Table 1. Demographics and clinical outcomes of five patients with ampullary cancer Time of Tumor Time to Age Differentia survival/ Sex Staging size Morphology Recurrence recurrence Condition (years) tion expired (cm) (months) (months) T2N0, 51 F 211 Polypoid Unknown No -- Survived 193 stage Ib T2N0, 2.41.5 58 F Mixed Good Yes 14 Expired 17 stage Ib 0.6 T3N0, 4.53.5 68 M Polypoid Good No -- Survived 162 stage IIA 1.2 T3N0, 66 M 110.8 Ulcerative Good Yes 64 Expired 227 stage IIA T3N0, 60 M 21.81 Mixed Moderate Yes 5.6 Expired 16.7 stage IIA 2 Supplementary Table 2. Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis of an ampullary cancer microarray using the Database for Annotation, Visualization and Integrated Discovery (DAVID). This table contains only pathways with p values that ranged 0.0001~0.05. KEGG Pathway p value Genes Pentose and 1.50E-04 UGT1A6, CRYL1, UGT1A8, AKR1B1, UGT2B11, UGT2A3, glucuronate UGT2B10, UGT2B7, XYLB interconversions Drug metabolism 1.63E-04 CYP3A4, XDH, UGT1A6, CYP3A5, CES2, CYP3A7, UGT1A8, NAT2, UGT2B11, DPYD, UGT2A3, UGT2B10, UGT2B7 Maturity-onset 2.43E-04 HNF1A, HNF4A, SLC2A2, PKLR, NEUROD1, HNF4G, diabetes of the PDX1, NR5A2, NKX2-2 young Starch and sucrose 6.03E-04 GBA3, UGT1A6, G6PC, UGT1A8, ENPP3, MGAM, SI, metabolism -
Product Monograph
PRODUCT MONOGRAPH PrFLUANXOL® Flupentixol Tablets (as flupentixol dihydrochloride) 0.5 mg, 3 mg, and 5 mg PrFLUANXOL® DEPOT Flupentixol Decanoate Intramuscular Injection 2% and 10% flupentixol decanoate Antipsychotic Agent Lundbeck Canada Inc. Date of Revision: 2600 Alfred-Nobel December 12th, 2017 Suite 400 St-Laurent, QC H4S 0A9 Submission Control No : 209135 Page 1 of 35 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 -
Title 21 Food and Drugs Part 1300 to End
Title 21 Food and Drugs Part 1300 to End Revised as of April 1, 2011 Containing a codification of documents of general applicability and future effect As of April 1, 2011 Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register VerDate Mar<15>2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Y:\SGML\223073.XXX 223073 erowe on DSK5CLS3C1PROD with CFR U.S. GOVERNMENT OFFICIAL EDITION NOTICE Legal Status and Use of Seals and Logos The seal of the National Archives and Records Administration (NARA) authenticates the Code of Federal Regulations (CFR) as the official codification of Federal regulations established under the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the contents of the CFR, a special edition of the Federal Register, shall be judicially noticed. The CFR is prima facie evidence of the origi- nal documents published in the Federal Register (44 U.S.C. 1510). It is prohibited to use NARA’s official seal and the stylized Code of Federal Regulations logo on any republication of this material without the express, written permission of the Archivist of the United States or the Archivist’s designee. Any person using NARA’s official seals and logos in a manner inconsistent with the provisions of 36 CFR part 1200 is subject to the penalties specified in 18 U.S.C. 506, 701, and 1017. Use of ISBN Prefix This is the Official U.S. Government edition of this publication and is herein identified to certify its authenticity. -
Poisons and Narcotic Drugs (Amendment) Ordinance 1988
AUSTRALIAN CAPITAL TERRITORY Poisons and Narcotic Drugs (Amendment) Ordinance 1988 No. 96 of 1988 I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Ordinance under the Seat of Government (Administration) Act 1910. Dated 15 December 1988 N. M. STEPHEN Governor-General By His Excellency’s Command, CLYDE HOLDING Minister of State for the Arts and Territories An Ordinance to amend the Poisons and Narcotic Drugs Ordinance 1978 Short title 1. This Ordinance may be cited as the Poisons and Narcotic Drugs (Amendment) Ordinance 1988.1 Commencement 2. This Ordinance commences on such date as is fixed by the Minister by notice in the Gazette. Principal Ordinance 3. In this Ordinance, “Principal Ordinance” means the Poisons and Narcotic Drugs Ordinance 1978.2 (Ord. 79/88)—Cat. No. Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au 2 Poisons and Narcotic Drugs (Amendment) No. 96, 1988 Substances to which Division applies 4. Section 27B of the Principal Ordinance is amended by adding at the end the following paragraphs: “; (f) follicle stimulating hormone; (g) luteinising hormone; (h) thalidomide.”. Grant of authorisation 5. Section 27E of the Principal Ordinance is amended— (a) by omitting from paragraph (1) (a) “or cyclofenil” and substituting “, cyclofenil, follicle stimulating hormone or luteinising hormone”; (b) by omitting from paragraph (1) (b) “and”; and (c) by adding at the end of subsection (1) the following word and paragraph: “; and (d) in the case of an application that relates to thalidomide— the applicant is a specialist physician with no less than 5 years’ experience in the treatment of erythema nodosum leprosum.”. -
Characterization of Mice with Altered Dopamine Transporter and Vesicular Monoamine Transporter 2 Levels
Characterization of Mice with Altered Dopamine Transporter and Vesicular Monoamine Transporter 2 Levels by Shababa Tanzeel Masoud A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Pharmacology and Toxicology University of Toronto © Copyright by Shababa Tanzeel Masoud 2017 Characterization of Mice with Altered Dopamine Transporter and Vesicular Monoamine Transporter 2 Levels Shababa Tanzeel Masoud Doctor of Philosophy Department of Pharmacology and Toxicology University of Toronto 2017 Abstract Dopamine is a key neurotransmitter that regulates motor coordination and dysfunction of the dopamine system gives rise to Parkinson’s disease. Nigrostriatal dopamine neurons are vulnerable to various genetic and environmental insults, suggesting that these cells are inherently at-risk. A cell-specific risk factor for these neurons is the neurotransmitter, dopamine itself. If intracellular dopamine is not appropriately sequestered into vesicles, it can accumulate in the cytosol. Cytosolic dopamine is highly reactive and can trigger oxidative stress, leading to cellular toxicity. Cytosolic dopamine levels are modulated by the plasma membrane dopamine transporter (DAT) that takes up dopamine from the extracellular space, and the vesicular monoamine transporter 2 (VMAT2) that stores dopamine into vesicles. In this thesis, we altered DAT and VMAT2 levels to investigate the detrimental consequences of potentially amplifying cytosolic dopamine in transgenic mice. Project 1 focused on selective over-expression of DAT in dopaminergic cells of transgenic mice (DAT-tg). DAT-tg mice displayed phenotypes of dopaminergic damage: increased dopamine-specific oxidative stress, L-DOPA-reversible fine motor deficits and enhanced sensitivity to toxicant insult, suggesting that increasing DAT- mediated dopamine uptake is detrimental for dopamine cells. -
Acute Toxicity Associated with the Recreational Use of the Novel Dissociative Psychoactive Substance Methoxphenidine
Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2014 Acute toxicity associated with the recreational use of the novel dissociative psychoactive substance methoxphenidine Hofer, K E ; Degrandi, C ; Müller, D M ; Zürrer-Härdi, U ; Wahl, S ; Rauber-Lüthy, C ; Ceschi, A Abstract: INTRODUCTION: Methoxphenidine is a novel dissociative designer drug of the diarylethy- lamine class which shares structural features with phencyclidine (PCP), and is not at present subject to restrictive regulations. There is very limited information about the acute toxicity profile of methoxpheni- dine and the only sources are anonymous internet sites and a 1989 patent of the Searle Company. We report a case of analytically confirmed oral methoxphenidine toxicity. CASE DETAILS: A 53-year-old man was found on the street in a somnolent and confusional state. Observed signs and symptoms such as tachycardia (112 bpm), hypertension (220/125 mmHg), echolalia, confusion, agitation, opisthotonus, nys- tagmus and amnesia were consistent with phencyclidine-induced adverse effects. Temperature (99.1°F (37.3°C)) and peripheral oxygen saturation while breathing room air (99%) were normal. Laboratory analysis revealed an increase of creatine kinase (max 865 U/L), alanine aminotransferase (72 U/L) and gamma-glutamyl transpeptidase (123 U/L). Methoxphenidine was identified by a liquid chromatogra- phy tandem mass spectrometry toxicological screening method using turbulent flow online extraction in plasma and urine samples collected on admission. The clinical course was favourable and signs and symptoms resolved with symptomatic treatment. CONCLUSION: Based on this case report and users’ web reports, and compatible with the chemical structure, methoxphenidine produces effects similar to those of the arylcyclohexylamines, as PCP. -
Depot Antipsychotic Injections
Mental Health Services Good Practice Statement For The Use Of DEPOT & LONG ACTING ANTIPSYCHOTIC INJECTIONS Date of Revision: February 2020 Approved by: Mental Health Prescribing Management Group Review Date: CONSULTATION The document was sent to Community Mental Health teams, Pharmacy and the Psychiatric Advisory Committee for comments prior to completion. KEY DOCUMENTS When reading this policy please consult the NHS Consent Policy when considering any aspect of consent National Institute for Clinical Excellence CG178 (2014), Psychosis and schizophrenia in adults: prevention and management NHS Lothian (2011), Depot Antipsychotic Guidance, Maudsley (2015), Prescribing Guidelines in Psychiatry 12th edition. UKPPG (2009) Guidance on the Administration to Adults of Oil based Depot and other Long Acting Intramuscular Antipsychotic Injections Summary of Product Characteristics for: Clopixol (Zuclopethixol Decanoate) Flupenthixol Decanoate Haldol (Haloperidol Decanoate) Risperdal Consta Xeplion (Paliperidone Palmitate) ZypAdhera (Olanzapine Embonate) Abilify Maintena (Aripiprazole) 1 CONTENTS REFERENCES/KEY DOCUMENTS …………………………………………………………… 1 INTRODUCTION …………………………………………………………………………………. 3 SCOPE …………………………………………………………………………………………….. 3 DEFINITIONS ……………………………………………………………………………………... 3 CHOICE OF DRUG AND DOSAGE SELECTION ……………………………………………. 3 SIDE EFFECTS ……………………………………………………………….………………….. 5 PRESCRIBING …………………………………………………………………………………… 5 ADMINISTRATION ………………………………………………………………………………. 7 RECORDING ADMINISTRATION ……………………………………………………………… 7 -
Compositions and Methods for Selective Delivery of Oligonucleotide Molecules to Specific Neuron Types
(19) TZZ ¥Z_T (11) EP 2 380 595 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 26.10.2011 Bulletin 2011/43 A61K 47/48 (2006.01) C12N 15/11 (2006.01) A61P 25/00 (2006.01) A61K 49/00 (2006.01) (2006.01) (21) Application number: 10382087.4 A61K 51/00 (22) Date of filing: 19.04.2010 (84) Designated Contracting States: • Alvarado Urbina, Gabriel AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Nepean Ontario K2G 4Z1 (CA) HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL • Bortolozzi Biassoni, Analia Alejandra PT RO SE SI SK SM TR E-08036, Barcelona (ES) Designated Extension States: • Artigas Perez, Francesc AL BA ME RS E-08036, Barcelona (ES) • Vila Bover, Miquel (71) Applicant: Nlife Therapeutics S.L. 15006 La Coruna (ES) E-08035, Barcelona (ES) (72) Inventors: (74) Representative: ABG Patentes, S.L. • Montefeltro, Andrés Pablo Avenida de Burgos 16D E-08014, Barcelon (ES) Edificio Euromor 28036 Madrid (ES) (54) Compositions and methods for selective delivery of oligonucleotide molecules to specific neuron types (57) The invention provides a conjugate comprising nucleuc acid toi cell of interests and thus, for the treat- (i) a nucleic acid which is complementary to a target nu- ment of diseases which require a down-regulation of the cleic acid sequence and which expression prevents or protein encoded by the target nucleic acid as well as for reduces expression of the target nucleic acid and (ii) a the delivery of contrast agents to the cells for diagnostic selectivity agent which is capable of binding with high purposes.