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Determination of Quifenadine by HPLC Method in Blood
ISSN 2311-715X (Print) Український біофармацевтичний журнал, № 3 (64) 2020 ISSN 2519-8750 (Online) UDC 615.218:001.891:543.42:543.544 https://doi.org/10.24959/ubphj.20.277 O.National Mamina, University V. Kabachny, of Pharmacy O. Lozova* of the Ministry of Health of Ukraine * Private Higher Educational Institution “Kyiv Medical University” determination of quifenadine by HPLC method in blood Topicality. - tion H1-histamine receptor blocker. The drug reduces the content of histamine in tissues due to the activation of the enzyme Quifenadine hydrochloride (phencarol) – quinuclidinyl-3-diphenyl carbinol hydrochloride – first genera- diamine oxidase, which breaks down up to 30 % of tissue histamine. Quifenadine hydrochloride is superior to diphenhy dramine in duration of antihistamine action. Unlike diphenhydramine and diprazine, quifenadine does not inhibit the CNS, is characterized by weak sedative properties. Quifenadine hydrochloride can be used in the development of tolerance to other sedative antihistamines. Quifenadine hydrochloride is used to treat anaphylactic shock, urticaria, hay fever, Quincke’s edema, dermatoses, allergic rhinitis, food and drug allergies. In case of overdose of quifenadine hydrochloride- chloridecauses dryness in pharmaceuticals of the mucous and membranes, biological headache, matrices duringvomiting, treatment stomach are pain based and dyspepsia.on the choice At highof highly doses, sensitive it can affect and the cardiovascular system, gastrointestinal tract, liver and kidneys. Detection and quantification of quifenadine hydro antihistamines and diagnosis of drug intoxication. selectiveAim. research methods, which is an urgent task for monitoring the effectiveness of treatment of the population with Materials To develop and methods. an algorithm for directed analysis of quifenadine in biological extracts from blood using a unified method of HPLC research. -
Specialty Drug List 10-22-12 Final
Iowa Medicaid Specialty Drug List Effective 10/22/2012 “Specialty” drugs include biological drugs, blood-derived products, complex molecules, and select oral, injectable, and infused medications identified by the Department and reimbursed at AWP-17% plus the dispensing fee. Specialty pricing will be applied to both the brand and generic drug products. NOTE: See the PDL at www.iowamedicaidpdl.com for specific PA criteria for the following drugs. BRAND NAME GENERIC NAME AGENTS FOR GAUCHER DISEASE ELELYSO taliglucerase alfa VPRIV velaglucerase alfa ALS RILUTEK riluzole ALCOHOL DEPENDENCE VIVITROL naltrexone AMINOGLYCOSIDES TOBI tobramycin ANTI-ASTHMATICS ALPHA PROTEINASE INHIBITORS ARALAST proteinase inhibitor ARALAST NP proteinase inhibitor PROLASTIN, C proteinase inhibitor ZEMAIRA alpha-1 proteinase inhibitor ANTIASTHMATIC - BETA - ADRENERGICS BRETHINE INJECTION turbutaline sulfate ANTIASTHMATIC - HYDRO-LYTIC ENZYMES KALYDECO ivacaftor ANTIBIOTICS - MISC. CAYSTON aztreonam lysine for inhal soln ANTI-CATAPLECTIC AGENTS XYREM sodium oxybate oral solution ANTICOAGULANTS ARIXTRA fondaparinux sodium FRAGMIN dalteparin sodium INNOHEP tinzaparin sodium LOVENOX enoxaparin sodium ANTICONVULSANTS SABRIL vigabatrin ANTIDOTES FERRIPROX deferiprone ANTIDOTES - CHELATING AGENTS CHEMET succimer EXJADE deferasirox tab for oral susp Page 1 of 10 ANTIEMETIC - TETRAHYDROCANNABINOL (THC) DERIVATIVES MARINOL dronabinol ANTIFUNGALS - ASSORTED AMBISOME amphotericin B Liposome IV for suspension ANCOBON flucytosine CANCIDAS caspofungin acetate for IV solution -
AUBAGIO* (Teriflunomide)
AUBAGIO* (teriflunomide) * Bolded medications are the preferred products RATIONALE FOR INCLUSION IN PA PROGRAM Background Aubagio (teriflunomide) is indicated for relapsing multiple sclerosis. It is an anti-inflammatory immunomodulatory agent, which inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown, but may involve a reduction in the number of activated lymphocytes in the CNS (1). Regulatory Status FDA-approved indication: Aubagio is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease (1). The Aubagio label includes a boxed warning citing the risk of hepatotoxicity. Aubagio is contraindicated in patients with severe hepatic impairment. Severe liver injury, including fatal liver failure, has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of Aubagio with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of Aubagio and monitor ALT levels at least monthly for six months after starting Aubagio. If drug induced liver injury is suspected, discontinue Aubagio and start an accelerated elimination procedure. Elimination of Aubagio can be accelerated by administration of cholestyramine or activated charcoal for 11 days (1). Aubagio also carries a boxed warning on the risk of teratogenicity. -
WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT
(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 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
Peptide Therapeutics Designing a Science-Led Strategic Quality Control Program
BioProcess International Peptide SPECIAL REPORT Therapeutics Designing a Science-Led Strategic Quality Control Program INTERTEK PHARMACEUTICAL SERVICES Your partner for regulatory-driven, phase appropriate analytical programs tailored to your molecule. Our experts help you to navigate the challenges of development, regulatory submission, and manufacturing. Peptide Therapeutics Designing a Science-Led Strategic Quality Control Program Shashank Sharma and Hannah Lee ince the emergence of peptide therapeutics in the 1920s with the advent of insulin therapy, the market for this product class has continued to expand with global revenues anticipatedS to surpass US$50 billion by 2024 (1). The growth of peptide therapeutics is attributed not only to improvements in manufacturing, but also to a rise in demand because of an increasingly aging population that is driving an increase in the occurrence of long-term diseases. The need for efficient and low-cost drugs and rising investments in research and development of novel drugs continues to boost market growth and fuel the emergence of generic versions that offer patients access to vital medicines at low costs. North America has been the dominant market for peptide therapeutics, with the Asia–Pacific region Insulin molecular model; the first therapeutic expected to grow at a faster rate. The global peptides use of this peptide hormone was in the market has attracted the attention of key players 1920s to treat diabetic patients. within the pharmaceutical industry, including Teva Pharmaceuticals, Eli Lilly, Novo Nordisk, Pfizer, amino acids to be peptides. Within that set, those Takeda, and Amgen. Those companies have made containing 10 or more are classed as polypeptides. -
Linaclotide: a Novel Therapy for Chronic Constipation and Constipation- Predominant Irritable Bowel Syndrome Brian E
Linaclotide: A Novel Therapy for Chronic Constipation and Constipation- Predominant Irritable Bowel Syndrome Brian E. Lacy, PhD, MD, John M. Levenick, MD, and Michael D. Crowell, PhD, FACG Dr. Lacy is Section Chief of Gastroenter- Abstract: Chronic constipation and irritable bowel syndrome ology and Hepatology and Dr. Levenick (IBS) are functional gastrointestinal disorders that significantly is a Gastroenterology Fellow in the affect patients’ quality of life. Chronic constipation and IBS are Division of Gastroenterology and prevalent—12% of the US population meet the diagnostic crite- Hepatology at Dartmouth-Hitchcock Medical Center in Lebanon, New ria for IBS, and 15% meet the criteria for chronic constipation— Hampshire. Dr. Crowell is a Professor and these conditions negatively impact the healthcare system of Medicine in the Division of from an economic perspective. Despite attempts at dietary Gastroenterology and Hepatology at modification, exercise, or use of over-the-counter medications, Mayo Clinic in Scottsdale, Arizona. many patients have persistent symptoms. Alternative treatment options are limited. This article describes linaclotide (Linzess, Address correspondence to: Dr. Brian E. Lacy Ironwood Pharmaceuticals/Forest Pharmaceuticals), a new, first- Division of Gastroenterology and in-class medication for the treatment of chronic constipation Hepatology, Area 4C and constipation-predominant IBS. Dartmouth-Hitchcock Medical Center 1 Medical Center Drive Lebanon, NH 03756; Tel: 603-650-5215; Fax: 603-650-5225; onstipation is -
Laxatives for the Management of Constipation in People Receiving Palliative Care (Review)
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by UCL Discovery Laxatives for the management of constipation in people receiving palliative care (Review) Candy B, Jones L, Larkin PJ, Vickerstaff V, Tookman A, Stone P This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 5 http://www.thecochranelibrary.com Laxatives for the management of constipation in people receiving palliative care (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 4 METHODS ...................................... 4 RESULTS....................................... 7 Figure1. ..................................... 8 Figure2. ..................................... 9 Figure3. ..................................... 10 DISCUSSION ..................................... 13 AUTHORS’CONCLUSIONS . 14 ACKNOWLEDGEMENTS . 14 REFERENCES ..................................... 15 CHARACTERISTICSOFSTUDIES . 17 DATAANDANALYSES. 26 ADDITIONALTABLES. 26 APPENDICES ..................................... 28 WHAT’SNEW..................................... 35 HISTORY....................................... 35 CONTRIBUTIONSOFAUTHORS . 36 DECLARATIONSOFINTEREST . 36 SOURCESOFSUPPORT . 36 DIFFERENCES -
Pharmacology on Your Palms CLASSIFICATION of the DRUGS
Pharmacology on your palms CLASSIFICATION OF THE DRUGS DRUGS FROM DRUGS AFFECTING THE ORGANS CHEMOTHERAPEUTIC DIFFERENT DRUGS AFFECTING THE NERVOUS SYSTEM AND TISSUES DRUGS PHARMACOLOGICAL GROUPS Drugs affecting peripheral Antitumor drugs Drugs affecting the cardiovascular Antimicrobial, antiviral, Drugs affecting the nervous system Antiallergic drugs system antiparasitic drugs central nervous system Drugs affecting the sensory Antidotes nerve endings Cardiac glycosides Antibiotics CNS DEPRESSANTS (AFFECTING THE Antihypertensive drugs Sulfonamides Analgesics (opioid, AFFERENT INNERVATION) Antianginal drugs Antituberculous drugs analgesics-antipyretics, Antiarrhythmic drugs Antihelminthic drugs NSAIDs) Local anaesthetics Antihyperlipidemic drugs Antifungal drugs Sedative and hypnotic Coating drugs Spasmolytics Antiviral drugs drugs Adsorbents Drugs affecting the excretory system Antimalarial drugs Tranquilizers Astringents Diuretics Antisyphilitic drugs Neuroleptics Expectorants Drugs affecting the hemopoietic system Antiseptics Anticonvulsants Irritant drugs Drugs affecting blood coagulation Disinfectants Antiparkinsonian drugs Drugs affecting peripheral Drugs affecting erythro- and leukopoiesis General anaesthetics neurotransmitter processes Drugs affecting the digestive system CNS STIMULANTS (AFFECTING THE Anorectic drugs Psychomotor stimulants EFFERENT PART OF THE Bitter stuffs. Drugs for replacement therapy Analeptics NERVOUS SYSTEM) Antiacid drugs Antidepressants Direct-acting-cholinomimetics Antiulcer drugs Nootropics (Cognitive -
Physiologically Based Pharmacokinetic Modeling in Regulatory Decision‐Making at the European Medicines Agency
ARTICLES Physiologically Based Pharmacokinetic Modeling in Regulatory Decision-Making at the European Medicines Agency E Luzon1, K Blake1, S Cole2,3,4, A Nordmark4,5, C Versantvoort3,6 and E Gil Berglund3,5 Physiologically based pharmacokinetic (PBPK) modeling is a valuable tool in drug development and regulatory assessment, as it offers the opportunity to simulate the pharmacokinetics of a compound, with a mechanistic understanding, in a variety of populations and situations. This work reviews the use and impact of such modeling in selected regulatory procedures submitted to the European Medicines Agency (EMA) before the end of 2015, together with its subsequent reflection in public documents relating to the assessment of these procedures. It is apparent that the reference to PBPK modeling in regulatory public documents underrepresents its use. A positive trend over time of the number of PBPK models submitted is shown, and in a number of cases the results of these may impact the decision- making process or lead to recommendations in the product labeling. These results confirm the need for regulatory guidance in this field, which is currently under development by the EMA. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE WHAT THIS STUDY ADDS TO OUR KNOWLEDGE TOPIC? þ This is the first work presenting the situation in the Europe- þ PBPK is a cutting-edge technology that is increasingly being an Union and confirms what was detected by the FDA is a applied to drug development to address various aspects related global trend. to clinical pharmacology. Previous works by the FDA acknowl- HOW THIS MIGHT CHANGE CLINICAL PHARMA- edge its use in regulatory submissions in the US, but so far there COLOGY OR TRANSLATIONAL SCIENCE is no analysis of the European perspective. -
Workbook Psychiatry and Narcology
Kharkiv National Medical University Department of Psychiatry, Narcology and Medical Psychology WORKBOOK MANUAL FOR INDIVIDUAL WORK FOR MEDICAL STUDENTS PSYCHIATRY AND NARCOLOGY (Part 2) Student ___________________________________________________________ Faculty _________________________________________________________ Course _________________ Group _____________________________________ Kharkiv 2019 Затверджено вченою радою ХНМУ Протокол №5 від 23.05.2019 р. Psychiatry (Part 2) : workbook manual for individual work of students / I. Strelnikova, G. Samardacova, К. Zelenska – Kharkiv, 2019. – 103 p. Копіювання для розповсюдження в будь-якому вигляді частин або повністю можливо тільки з дозволу авторів навчального посібника. CLASS 7. NEUROTIC DISORDERS. CLINICAL FORMS. TREATMENT AND REHABILITATION. POSTTRAUMATIC STRESS DISORDER. TREATMENT AND REHABILITATION. Psychogenic diseases are a large and clinically varied group of diseases resulting from an effect of acute or long-term psychic traumas, which manifest themselves by both mental and somatoneurological disorders and, as a rule, are reversible. Psychogenic diseases are caused by a psychic trauma, i.e. some events which affect significant aspects of existence of the human being and result in deep psychological feelings. These may be subjectively significant events, i.e. those which are pathogenic for the majority of people. Besides, the psyche may be traumatized by conventionally pathogenic events, which cause feelings in an individual because of his peculiar hierarchy of values. Unfavorable psychogenic effects on the human being cause stress in him, i.e. a nonspecific reaction at the physiological, psychological and behavioural levels. Stress may exert some positive, mobilizing influence, but may result in disorganization of the organism activity. The stress, which exerts a negative influence and causes various disturbances and even diseases, is termed distress. Classification of neurotic disorders I. -
Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Cr
Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Crizotinib (PF-02341066) 1 4 55 Docetaxel 1 5 98 Anastrozole 1 6 25 Cladribine 1 7 23 Methotrexate 1 8 -187 Letrozole 1 9 65 Entecavir Hydrate 1 10 48 Roxadustat (FG-4592) 1 11 19 Imatinib Mesylate (STI571) 1 12 0 Sunitinib Malate 1 13 34 Vismodegib (GDC-0449) 1 14 64 Paclitaxel 1 15 89 Aprepitant 1 16 94 Decitabine 1 17 -79 Bendamustine HCl 1 18 19 Temozolomide 1 19 -111 Nepafenac 1 20 24 Nintedanib (BIBF 1120) 1 21 -43 Lapatinib (GW-572016) Ditosylate 1 22 88 Temsirolimus (CCI-779, NSC 683864) 1 23 96 Belinostat (PXD101) 1 24 46 Capecitabine 1 25 19 Bicalutamide 1 26 83 Dutasteride 1 27 68 Epirubicin HCl 1 28 -59 Tamoxifen 1 29 30 Rufinamide 1 30 96 Afatinib (BIBW2992) 1 31 -54 Lenalidomide (CC-5013) 1 32 19 Vorinostat (SAHA, MK0683) 1 33 38 Rucaparib (AG-014699,PF-01367338) phosphate1 34 14 Lenvatinib (E7080) 1 35 80 Fulvestrant 1 36 76 Melatonin 1 37 15 Etoposide 1 38 -69 Vincristine sulfate 1 39 61 Posaconazole 1 40 97 Bortezomib (PS-341) 1 41 71 Panobinostat (LBH589) 1 42 41 Entinostat (MS-275) 1 43 26 Cabozantinib (XL184, BMS-907351) 1 44 79 Valproic acid sodium salt (Sodium valproate) 1 45 7 Raltitrexed 1 46 39 Bisoprolol fumarate 1 47 -23 Raloxifene HCl 1 48 97 Agomelatine 1 49 35 Prasugrel 1 50 -24 Bosutinib (SKI-606) 1 51 85 Nilotinib (AMN-107) 1 52 99 Enzastaurin (LY317615) 1 53 -12 Everolimus (RAD001) 1 54 94 Regorafenib (BAY 73-4506) 1 55 24 Thalidomide 1 56 40 Tivozanib (AV-951) 1 57 86 Fludarabine -
COMPARISON of the WHO ATC CLASSIFICATION & Ephmra/Intellus Worldwide ANATOMICAL CLASSIFICATION
COMPARISON OF THE WHO ATC CLASSIFICATION & EphMRA/Intellus Worldwide ANATOMICAL CLASSIFICATION: VERSION June 2019 2 Comparison of the WHO ATC Classification and EphMRA / Intellus Worldwide Anatomical Classification The following booklet is designed to improve the understanding of the two classification systems. The development of the two systems had previously taken place separately. EphMRA and WHO are now working together to ensure that there is a convergence of the 2 systems rather than a divergence. In order to better understand the two classification systems, we should pay attention to the way in which substances/products are classified. WHO mainly classifies substances according to the therapeutic or pharmaceutical aspects and in one class only (particular formulations or strengths can be given separate codes, e.g. clonidine in C02A as antihypertensive agent, N02C as anti-migraine product and S01E as ophthalmic product). EphMRA classifies products, mainly according to their indications and use. Therefore, it is possible to find the same compound in several classes, depending on the product, e.g., NAPROXEN tablets can be classified in M1A (antirheumatic), N2B (analgesic) and G2C if indicated for gynaecological conditions only. The purposes of classification are also different: The main purpose of the WHO classification is for international drug utilisation research and for adverse drug reaction monitoring. This classification is recommended by the WHO for use in international drug utilisation research. The EphMRA/Intellus Worldwide classification has a primary objective to satisfy the marketing needs of the pharmaceutical companies. Therefore, a direct comparison is sometimes difficult due to the different nature and purpose of the two systems.