Jasvinder Singh, MD
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Specifications of Approved Drug Compound Library
Annexure-I : Specifications of Approved drug compound library The compounds should be structurally diverse, medicinally active, and cell permeable Compounds should have rich documentation with structure, Target, Activity and IC50 should be known Compounds which are supplied should have been validated by NMR and HPLC to ensure high purity Each compound should be supplied as 10mM solution in DMSO and at least 100µl of each compound should be supplied. Compounds should be supplied in screw capped vial arranged as 96 well plate format. -
A Novel Approach to the Development of Response Criteria for Chronic Gout Clinical Trials
Bringing It All Together: A Novel Approach to the Development of Response Criteria for Chronic Gout Clinical Trials WILLIAM J. TAYLOR, JASVINDER A. SINGH, KENNETH G. SAAG, NICOLA DALBETH, PATRICIA A. MacDONALD, N. LAWRENCE EDWARDS, LEE S. SIMON, LISA K. STAMP, TUHINA NEOGI, ANGELO L. GAFFO, PUJA P. KHANNA, MICHAEL A. BECKER, and H. RALPH SCHUMACHER Jr ABSTRACT. Objective. To review a novel approach for constructing composite response criteria for use in chronic gout clinical trials that implements a method of multicriteria decision-making. Methods. Preliminary work with paper patient profiles led to a restricted set of core-set domains that were examined using 1000MindsTM by rheumatologists with an interest in gout, and (separately) by OMERACT registrants prior to OMERACT 10. These results and the 1000Minds approach were dis- cussed during OMERACT 10 to help guide next steps in developing composite response criteria. Results. There were differences in how individual indicators of response were weighted between gout experts and OMERACT registrants. Gout experts placed more weight upon changes in uric acid levels, whereas OMERACT registrants placed more weight upon reducing flares. Discussion highlighted the need for a “pain” domain to be included, for “worsening” to be an additional level within each indica- tor, for a group process to determine the decision-making within a 1000Minds exercise, and for the value of patient involvement. Conclusion. Although there was not unanimous support for the 1000Minds approach to inform the con- struction of composite response criteria, there is sufficient interest to justify ongoing development of this methodology and its application to real clinical trial data. -
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 -
Biologic Drugs in the Treatment of Myositis
BIOLOGIC DRUGS IN THE TREATMENT OF MYOSITIS Professor David Isenberg University College London, UK KEY FACTS – 1 - • Incidence of PM/DM/IBM 1.9-7.7 million • Prevalence in the UK = 8/100,000 • Affects all ages but 2 peaks of onset; childhood onset 5-15 and adult onset 40-60. IBM peaks after 50 years. • DM/PM overall F:M ratio = 2-3:1 KEY FACTS – 2 – CLINICAL CLASSIFICATION • Adult onset idiopathic polymyositis • Adult onset idiopathic dermatomyositis • Childhood onset myositis (invariably dermatomyositis) • Myositis associated with other autoimmune rheumatic disease • Inclusion body myositis • Rare forms: focal, ocular, eosinophilic, granulomatous myositis • Cancer associated myositis KEY FACTS – 3 – A MULTISYSTEM DISEASE • Constitutional – fever, wt loss, nodes, fatigue • Joints – arthralgia, arthritis • Gastrointestinal – dysphagia, abdo pain • Cardiovascular – palpitations, chest pain SKIN – RASHES, ERYTHEMA, ULCERATION AND ERYTHRODERMA MUSCLE – MYALGIA, WEAKNESS Polymyositis: histopathological features Mechanisms in Rheumatology ©2001 Dermatomyositis: histopathological features Mechanisms in Rheumatology ©2001 Respiratory – dysphonia, dyspnoea TRADITIONAL METHODS OF ASSESSING MYOSITIS Clinical Enzymes EMG Biopsy ACTIVITY- MITAX ASSESSMENT OF OUTCOME Idiopathic Inflammatory myopathies PATIENT’S DAMAGE- PERCEPTION- MYODAM SF-36 CURRENT ASSESSMENT OF MYOSITIS – 1 - Activity Damage Clinical rash, arthritis, fever, MMT, Atrophy, contractures myalgia Laboratory ↑ Muscle enzymes ↓ Creatinine, normal (CK, LDH, AST, ALT) enzymes Systemic -
Cross-Over Trial of Febuxostat and Topiroxostat for Hyperuricemia with Cardiovascular Disease (TROFEO Trial)
Circ J 2017; 81: 1707 – 1712 ORIGINAL ARTICLE doi: 10.1253/circj.CJ-17-0438 Preventive Medicine Cross-Over Trial of Febuxostat and Topiroxostat for Hyperuricemia With Cardiovascular Disease (TROFEO Trial) Akira Sezai, MD, PhD; Kazuaki Obata; Keisuke Abe; Sakie Kanno; Hisakuni Sekino, MD, PhD Background: We previously reported that febuxostat was more effective for hyperuricemia than allopurinol. The efficacy, however, of topiroxostat (a novel xanthine oxidase reductase inhibitor similar to febuxostat), for hyperuricemia is unknown. Methods and Results: Patients with cardiovascular disease and hyperuricemia, in whom serum uric acid (s-UA) was controlled at ≤6 mg/dL, were eligible for enrollment. Fifty-five patients were randomized to receive either febuxostat or topiroxostat for 6 months and were switched to the other drug for the following 6 months. The primary endpoint was s-UA. Secondary endpoints included serum creatinine, estimated glomerular filtration rate, urinary albumin, cystatin-C, oxidized low-density lipoprotein, eicosapentaenoic acid/ arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein and B-type natriuretic protein. Although s-UA level was similar for both drugs, significantly more patients required dose escalation during treatment with topiroxostat. There were no differ- ences in renal function, inflammatory and lipid markers between the 2 drugs. A biomarker of oxidative stress was significantly lower after 3 months of febuxostat compared with topiroxostat. Conclusions: Febuxostat causes more marked and more rapid reduction of s-UA than topiroxostat. With regard to the antioxidant effect, febuxostat was superior to topiroxostat after 3 months. The renal protective and anti-inflammatory effects of both drugs were also similar after 6 months of treatment. -
Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . -
Report on the Deliberation Results May 8, 2013 Evaluation And
Report on the Deliberation Results May 8, 2013 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] (a) Topiloric Tablets 20 mg, 40 mg, and 60 mg (b) Uriadec Tablets 20 mg, 40 mg, and 60 mg [Non-proprietary name] Topiroxostat (JAN*) [Applicant] (a) Fujiyakuhin Co., Ltd. (b) Sanwa Kagaku Kenkyusho Co., Ltd. [Date of application] June 26, 2012 [Results of deliberation] In the meeting held on April 26, 2013, the First Committee on New Drugs concluded that the product may be approved and that this result should be presented to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council. The product is not classified as a biological product or a specified biological product, the re-examination period is 8 years, and neither the drug substance nor the drug product is classified as a poisonous drug or a powerful drug. *Japanese Accepted Name (modified INN) This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report April 15, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name] (a) Topiloric Tablets 20 mg, 40 mg, and 60 mg (b) Uriadec Tablets 20 mg, 40 mg, and 60 mg [Non-proprietary name] Topiroxostat [Applicant] (a) Fujiyakuhin Co., Ltd. -
Copecare Publications 2016
COPECARE PUBLICATIONS 2016 JOURNAL PAPERS 2 LETTERS 10 REVIEWS 10 COMMENTS/DEBATES 10 CONFERENCE ABSTRACTS 11 BOOKS 22 REPORTS 22 PH.D. THESES 22 BOOK CHAPTERS/ANTHOLOGIES 22 POSTERS 23 NEWSPAPER ARTICLES 23 ONLINE PUBLICATIONS 23 OTHER PUBLICATIONS 24 Journal papers Three-dimensional Doppler ultrasound findings in healthy wrist and finger tendon sheaths - can feeding vessels lead to misinterpretation in Doppler-detected tenosynovitis? Ammitzbøll-Danielsen, M., Janta, I., Torp-Pedersen, S., Naredo, E., Østergaard, M. & Terslev, L., 18 mar. 2016, I : Arthritis Research and Therapy. 18, s. 70-77 7 s. Validity and sensitivity to change of the semi-quantitative OMERACT ultrasound scoring system for tenosynovitis in patients with rheumatoid arthritis Ammitzbøll-Danielsen, M., Østergaard, M., Naredo, E. & Terslev, L., dec. 2016, I : Rheumatology (Oxford, England). 55, 12, s. 2156-66 11 s. Associations between spondyloarthritis features and MRI findings: A cross-sectional analysis of 1020 patients with persistent low back pain Arnbak, B., Jurik, A. G., Hørslev-Petersen, K., Hendricks, O., Hermansen, L. T., Loft, A. G., Østergaard, M., Pedersen, S. J., Zejden, A., Egund, N., Holst, R., Manniche, C. & Jensen, T. S., 2016, I : Arthritis & rheumatology (Hoboken, N.J.). 68, 4, s. 892-900 9 s. The discriminative value of inflammatory back pain in patients with persistent low back pain Arnbak, B., Hendricks, O., Hørslev-Petersen, K., Jurik, A. G., Pedersen, S. J., Østergaard, M., Hermansen, L. T., Loft, A. G., Jensen, T. S. & Manniche, C., jul. 2016, I : Scandinavian Journal of Rheumatology. 45, 4, s. 321-8 8 s. Validity of early MRI structural damage end points and potential impact on clinical trial design in rheumatoid arthritis Baker, J. -
Metrochem API Private Limited
Metrochem API Private Limited APIs USDMF / CEP Numbers Submission Date Status Written Confirmation Acotiamide Alogliptin Benzoate Antazoline HCL CEP 2020-060 10 February,2020 Antazoline Phosphate USDMF 34330 1 January,2020 Apixaban USDMF 35518 30 December,2020 Apremilast Azilsartan Baloxavir Marboxil Product Under Validation Bempedoic Acid Bepotastine Besilate Bilastine Canagliflozin Cenobamate Cinitapride Clopidogrel Bisulfate Form I USDMF 34334 5 February,2020 Indian CDSCO WC-0493 Clopidogrel Bisulfate Form II USDMF 34334 5 February,2020 Indian CDSCO WC-0493 Crisaborole Dabigatran Dapaglifloin Amorphous Dapagliflozin Dexketoprofen Trometamol USDMF 34732 21 March,2020 Indian CDSCO WC-0493 Dexlansoprazole USDMF 34971 29 September,2020 Dexrabeprazole Dimethindene Maleate CEP 2021-080 6 February,2021 Edoxaban Efinaconazole Elagolix Elobixibat Product Under Validation Eltrombopag Empagliflozin USDMF 35345 31 October,2020 Indian CDSCO WC-0493 Empagliflozin Amorphous Ertugliflozin Esomeprazole Magnesium Dihydrate USDMF 35519 ; CEP 2021-022 29 December,2020 ; 28 December 2020 Note: None of the products will be supplied to the countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purpose only. However, the final responsibility exclusively lies with the buyer. Metrochem API Private Limited APIs USDMF / CEP Numbers Submission Date Status Written Confirmation Esomeprazole Magnesium Trihydrate USDMF 35400 ; CEP 2020-386 28 November,2020 ; 21 November,2020 Esomeprazole Sodium -
Autoinflammatory Disease Damage Index, 2016
Downloaded from http://ard.bmj.com/ on September 1, 2017 - Published by group.bmj.com Clinical and epidemiological research EXTENDED REPORT Development of the autoinflammatory disease damage index (ADDI) Nienke M ter Haar,1,2 Kim V Annink,3 Sulaiman M Al-Mayouf,4 Gayane Amaryan,5 Jordi Anton,6 Karyl S Barron,7 Susanne M Benseler,8 Paul A Brogan,9 Luca Cantarini,10 Marco Cattalini,11 Alexis-Virgil Cochino,12 Fabrizio De Benedetti,13 Fatma Dedeoglu,14 Adriana A De Jesus,15 Ornella Della Casa Alberighi,16 Erkan Demirkaya,17 Pavla Dolezalova,18 Karen L Durrant,19 Giovanna Fabio,20 Romina Gallizzi,21 Raphaela Goldbach-Mansky,15 Eric Hachulla,22 Veronique Hentgen,23 Troels Herlin,24 Michaël Hofer,25,26 Hal M Hoffman,27 Antonella Insalaco,28 Annette F Jansson,29 Tilmann Kallinich,30 Isabelle Koné-Paut,31 Anna Kozlova,32 Jasmin B Kuemmerle-Deschner,33 Helen J Lachmann,34 Ronald M Laxer,35 Alberto Martini,36 Susan Nielsen,37 Irina Nikishina,38 Amanda K Ombrello,39 Seza Ozen,40 Efimia Papadopoulou-Alataki,41 Pierre Quartier,42 Donato Rigante,43 Ricardo Russo,44 Anna Simon,45 Maria Trachana,46 Yosef Uziel,47 Angelo Ravelli,48 Marco Gattorno,49 Joost Frenkel3 Handling editor Tore K Kvien ABSTRACT INTRODUCTION Objectives Autoinflammatory diseases cause systemic Autoinflammatory diseases (AIDs) cover a spectrum For numbered affiliations see fl end of article. in ammation that can result in damage to multiple of diseases, which lead to chronic or recurrent organs. A validated instrument is essential to quantify inflammation caused by activation of the innate Correspondence to damage in individual patients and to compare disease immune system, typically in the absence of high- 1 Dr Nienke M ter Haar, outcomes in clinical studies. -
2010 Rheumatoid Arthritis Classification Criteria
ARTHRITIS & RHEUMATISM Vol. 62, No. 9, September 2010, pp 2569–2581 DOI 10.1002/art.27584 © 2010, American College of Rheumatology Arthritis & Rheumatism An Official Journal of the American College of Rheumatology www.arthritisrheum.org and www.interscience.wiley.com 2010 Rheumatoid Arthritis Classification Criteria An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative Daniel Aletaha,1 Tuhina Neogi,2 Alan J. Silman,3 Julia Funovits,1 David T. Felson,2 Clifton O. Bingham, III,4 Neal S. Birnbaum,5 Gerd R. Burmester,6 Vivian P. Bykerk,7 Marc D. Cohen,8 Bernard Combe,9 Karen H. Costenbader,10 Maxime Dougados,11 Paul Emery,12 Gianfranco Ferraccioli,13 Johanna M. W. Hazes,14 Kathryn Hobbs,15 Tom W. J. Huizinga,16 Arthur Kavanaugh,17 Jonathan Kay,18 Tore K. Kvien,19 Timothy Laing,20 Philip Mease,21 Henri A. Ménard,22 Larry W. Moreland,23 Raymond L. Naden,24 Theodore Pincus,25 Josef S. Smolen,1 Ewa Stanislawska-Biernat,26 Deborah Symmons,27 Paul P. Tak,28 Katherine S. Upchurch,18 Jirˇí Vencovsky´,29 Frederick Wolfe,30 and Gillian Hawker31 This criteria set has been approved by the American College of Rheumatology (ACR) Board of Directors and the Euro- pean League Against Rheumatism (EULAR) Executive Committee. This signifies that the criteria set has been quantita- tively validated using patient data, and it has undergone validation based on an external data set. All ACR/EULAR- approved criteria sets are expected to undergo intermittent updates. The American College of Rheumatology is an independent, professional, medical and scientific society which does not guarantee, warrant, or endorse any commercial product or service. -
Ardthe EULAR Journal Editor Josef S Smolen (Austria) and Disorders of Connective Tissue
Annals of the Rheumatic Diseases publishes original work on all aspects of rheumatology ARDThe EULAR Journal Editor Josef S Smolen (Austria) and disorders of connective tissue. Laboratory Associate Editors Tristan Barber (UK) and clinical studies are equally welcome Francis Berenbaum (France) Dimitrios Boumpas (Greece) Editorial Board Gerd Burmester (Germany) Daniel Aletaha (Austria) Robert Landewé (The Netherlands) Mary Crow (USA) Johan Askling (Sweden) Rik Lories (Belgium) Contact Details Iain McInnes (UK) Sang-Cheol Bae (Korea) Ingrid Lundberg (Sweden) Thomas Pap (Germany) Xenofon Baraliakos (Germany) Gary MacFarlane (UK) Editorial Office David Pisetsky (USA) Anne Barton (UK) Xavier Mariette (France) Annals of the Rheumatic Diseases Maarten Boers (The Alberto Martini (Italy) Désirée van der Heijde BMJ Journals, BMA House, Tavistock Square (The Netherlands) Netherlands) Dennis McGonagle (UK) London WCIH 9JR,UK Kazuhiko Yamamoto (Japan) Matthew Brown (Australia) Fred Miller (USA) Maya Buch (UK) Peter Nash (Australia) E: [email protected] Methodological and Statistical Loreto Carmona (Spain) Michael Nurmohamed (The Advisor Carlo Chizzolini (Switzerland) Netherlands) Production Editor Stian Lydersen (Norway) Bernard Combe (France) Caroline Ospelt (Switzerland) Teresa Jobson Philip Conaghan (UK) Monika Østensen (Norway) Social Media Editor E: [email protected] Harrison Austin (UK) Maurizio Cutolo (Italy) Constatino Pitzalis (UK) José da Silva (Portugal) Jane Salmon (USA) Social Media Advisors Nicola Dalbeth (Australia) Georg Schett (Germany)