NCL Red List at All NCL Trusts Except RNOH, Who Can Share Prescribing with a GP Within the Context of Their MDT OPAT Service
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Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
Bonviva, INN- Ibandronic Acid
European Medicines Agency London, 1 September 2005 Doc.Ref.: EMEA/278873/2005 Bonviva International Nonproprietary Name: Ibandronic acid Following the procedure EMEA/H/C/501/X/01 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: [email protected] http://www.emea.eu.int EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 1 SCIENTIFIC DISCUSSION 1.1 Introduction and rationale The MAH submitted an extension application under Annex II, point 2 iii to Commission Regulation (EC) No 1085/2003 to request the approval of a 150 mg tablet as a monthly dosing regimen of ibandronate only for the indication of “treatment of osteoporosis in postmenopausal women, in order to reduce the risk of vertebral fractures”. This claim is based on the results of a phase III study MOBILE (BM16549) comparing 100 and 150 mg once monthly to 2.5 mg once daily. Due to the inconveniences associated with intake of oral bisphosphonates (i.e. fasting conditions, frequent upper gastrointestinal intolerance) that may result in poor compliance, it was considered desirable to develop a more convenient drug formulation. Hence a 150 mg once monthly oral regimen is expected to offer greater convenience to postmenopausal women when compared to the currently approved 2.5mg once daily tablet. The development programme No new pre-clinical pharmacodynamic and pharmacokinetic studies have been performed in addition to those included in the previous submission for ibandronate 2.5 mg daily oral tablets. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Medicines Used Across Wirral Health Economy
Medicines used across Wirral Health Economy Below is a list of medicines that are approved for use on Wirral. Some medicines may only be prescribed in hospital, others may be prescribed by your GP. The list is updated every time a new medicine is approved for use in Wirral. Some medicines have been recommended by the National Institute for Health and Care Excellence (NICE). The middle column of the table below indicates recommendations made by NICE — eg, TA234 means that the medicine was reviewed in NICE technology appraisal number 234. Some of the medicines we use are recommended by specialists working from the Walton Centre NHS Foundation Trust or from the Cheshire and Wirral Partnership NHS Foundation Trust. These medicines are included in our formulary — however; the prescriber retains responsibility for the appropriate use of these medicines. These formularies are obtainable here: http://www.panmerseyapc.nhs.uk/formulary/documents/04- 0800_antiepileptic_drugs.pdf http://www.panmerseyapc.nhs.uk/formulary/documents/04-09- 00_parkinsonism.pdf http://www.cwp.nhs.uk/pages/629-pharmacy-and-medicines-information Subject to NICE Drug Name recommendation Abatacept TA195, TA280 Acamprosate Acarbose Accu-Chek Inform II® AccuSol® 35 Potassium 4mmol/L Acetazolamide Acetylcysteine Acencoumarol Acetic acid 5% solution Acetone Acitretin Aciclovir Wirral Medicines Formulary Author: Medicines Management Team Approved by: Wirral Drug and Therapeutics Panel Last updated: June 2015 Version 10 Aclinidium Actilite® Activated Charcoal Activon® - see -
Ten Years of the Hunter Outcome Survey (HOS): Insights, Achievements, and Lessons Learned from a Global Patient Registry Joseph Muenzer1, Simon A
Muenzer et al. Orphanet Journal of Rare Diseases (2017) 12:82 DOI 10.1186/s13023-017-0635-z REVIEW Open Access Ten years of the Hunter Outcome Survey (HOS): insights, achievements, and lessons learned from a global patient registry Joseph Muenzer1, Simon A. Jones2, Anna Tylki-Szymańska3, Paul Harmatz4, Nancy J. Mendelsohn5,6, Nathalie Guffon7, Roberto Giugliani8, Barbara K. Burton9, Maurizio Scarpa10,11, Michael Beck12, Yvonne Jangelind13, Elizabeth Hernberg-Stahl14, Maria Paabøl Larsen15,17, Tom Pulles16,18 and David A. H. Whiteman15* Abstract Mucopolysaccharidosis type II (MPS II; Hunter syndrome; OMIM 309900) is a rare lysosomal storage disease with progressive multisystem manifestations caused by deficient activity of the enzyme iduronate-2-sulfatase. Disease- specific treatment is available in the form of enzyme replacement therapy with intravenous idursulfase (Elaprase®, Shire). Since 2005, the Hunter Outcome Survey (HOS) has collected real-world, long-term data on the safety and effectiveness of this therapy, as well as the natural history of MPS II. Individuals with a confirmed diagnosis of MPS II who are untreated or who are receiving/have received treatment with idursulfase or bone marrow transplant can be enrolled in HOS. A broad range of disease- and treatment-related information is captured in the registry and, over the past decade, data from more than 1000 patients from 124 clinics in 29 countries have been collected. Evidence generated from HOS has helped to improve our understanding of disease progression in both treated and untreated patients and has extended findings from the formal clinical trials of idursulfase. As a long-term, global, observational registry, various challenges relating to data collection, entry, and analysis have been encountered. -
Publications in Scientific Journals (Peer Reviewed) 1
Last Updated July 2020 Publications in Scientific Journals (Peer Reviewed) 1. Eisengart JB, King KE, Shapiro EG, Whitley CB, Muenzer J. The nature and impact of neurobehavioral symptoms in neuronopathic Hunter syndrome. Mol Genet Metab Rep. 2019 Dec 20;22:100549. PMID: 32055445 2. Viskochil D, Clarke LA, Bay L, Keenan H, Muenzer J, Guffon N. Growth patterns for untreated individuals with MPS I: Report from the international MPS I registry. Am J Med Genet A. 2019 Dec;179(12):2425-2432. PMID: 31639289 3. Clarke LA, Giugliani R, Guffon N, Jones SA, Keenan HA, Munoz-Rojas MV, Okuyama T, Viskochil D, Whitley CB, Wijburg FA, Muenzer J. Genotype-phenotype relationships in mucopolysaccharidosis type I (MPS I): Insights from the International MPS I Registry. Clin Genet. 2019 Clin Genet. 2019 Oct;96(4):281-289. PMID: 31194252 4. Taylor JL, Clinard K, Powell CM, Rehder C, Young SP, Bali D, Beckloff SE, Gehtland LM, Kemper AR, Lee S, Millington D, Patel HS, Shone SM, Woodell C, Zimmerman SJ, Bailey DB Jr, Muenzer J. The North Carolina Experience with Mucopolysaccharidosis Type I Newborn Screening. J Pediatr. 2019 Aug;211:193-200. PMID: 31133280 5. Akyol MU, Alden TD, Amartino H, Ashworth J, Belani K, Berger KI, Borgo A, Braunlin E, Eto Y, Gold JI, Jester A, Jones SA, Karsli C, Mackenzie W, Marinho DR, McFadyen A, McGill J, Mitchell JJ, Muenzer J, Okuyama T, Orchard PJ, Stevens B, Thomas S, Walker R, Wynn R, Giugliani R, Harmatz P, Hendriksz C, Scarpa M; MPS Consensus Programme Steering Committee; MPS Consensus Programme Co-Chairs. -
CCA Senior Care Options Formulary
Commonwealth Care Alliance Senior Care Option HMO SNP 2021 List of Covered Drugs Formulary 30 Winter Street • Boston, MA 02108 PLEASE READ: THIS DOCUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN This formulary was updated on 08/01/2021. For more recent information or other questions, please contact Senior Care Options Program (HMO SNP) Member Services, at 1-866-610-2273 or, for TTY users, 711, 8 a.m. – 8 p.m., 7 days a week, or visit www.commonwealthcaresco.org. HPMS Approved Formulary File Submission ID 00021589, Version Number 13 Senior Care Options Program (HMO SNP) 2021 Formulary (List of Covered Drugs) PLEASE READ: THIS DO CUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN HPMS Approved Formulary File Submission ID 00021589, Version Number 13 Note to existing members: This formulary has changed since last year. Please review this document to make sure that it still contains the drugs you take. When this drug list (formulary) refers to “we,” “us”, or “our,” it means Commonwealth Care Alliance. When it refers to “plan” or “our plan,” it means 2021 Senior Care Options Program. This document includes list of the drugs (formulary) for our plan which is current as of 08/01/2021. This formulary document applies to all SCO members. For an updated formulary, please contact us. Our contact information, along with the date we last updated the formulary, appears on the front and back cover pages. You must generally use network pharmacies to use your prescription drug benefit. Benefits, formulary, pharmacy n etwork, and/or copayments/coinsurance may change on January 1, 2022, and from time to time during the year. -
PMBJP Product.Pdf
Sr. Drug Generic Name of the Medicine Unit Size MRP Therapeutic Category No. Code Analgesic & Antipyretic / Muscle 1 1 Aceclofenac 100mg and Paracetamol 325 mg Tablet 10's 10's 8.00 relaxants Analgesic & Antipyretic / Muscle 2 2 Aceclofenac Tablets IP 100mg 10's 10's 4.37 relaxants Acetaminophen 325 + Tramadol Hydrochloride 37.5 film Analgesic & Antipyretic / Muscle 3 4 10's 8.00 coated Tablet 10's relaxants Analgesic & Antipyretic / Muscle 4 5 ASPIRIN Tablets IP 150 mg 14's 14's 2.70 relaxants DICLOFENAC 50 mg+ PARACETAMOL 325 mg+ Analgesic & Antipyretic / Muscle 5 6 10's 11.30 CHLORZOXAZONE 500 mg Tablets 10's relaxants Diclofenac Sodium 50mg + Serratiopeptidase 10mg Tablet Analgesic & Antipyretic / Muscle 6 8 10's 12.00 10's relaxants Analgesic & Antipyretic / Muscle 7 9 Diclofenac Sodium (SR) 100 mg Tablet 10's 10's 6.12 relaxants Analgesic & Antipyretic / Muscle 8 10 Diclofenac Sodium 25mg per ml Inj. IP 3 ml 3 ml 2.00 relaxants Analgesic & Antipyretic / Muscle 9 11 Diclofenac Sodium 50 mg Tablet 10's 10's 2.90 relaxants Analgesic & Antipyretic / Muscle 10 12 Etoricoxilb Tablets IP 120mg 10's 10's 33.00 relaxants Analgesic & Antipyretic / Muscle 11 13 Etoricoxilb Tablets IP 90mg 10's 10's 25.00 relaxants Analgesic & Antipyretic / Muscle 12 14 Ibuprofen 400 mg + Paracetamol 325 mg Tablet 10's 15's 5.50 relaxants Analgesic & Antipyretic / Muscle 13 15 Ibuprofen 200 mg film coated Tablet 10's 10's 1.80 relaxants Analgesic & Antipyretic / Muscle 14 16 Ibuprofen 400 mg film coated Tablet 10's 15's 3.50 relaxants Analgesic & Antipyretic -
Enzyme Replacement Therapy Srx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment
MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 06/15/2011 03/15/2017 10/04/2016 Policy Name Policy Number Enzyme Replacement Therapy SRx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. -
Ep 1931310 B1
(19) & (11) EP 1 931 310 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/12 (2006.01) A61K 9/06 (2006.01) 06.06.2012 Bulletin 2012/23 A61K 9/70 (2006.01) A61K 47/32 (2006.01) A61K 47/24 (2006.01) A61K 47/10 (2006.01) (21) Application number: 06779420.6 (86) International application number: (22) Date of filing: 14.09.2006 PCT/GB2006/003408 (87) International publication number: WO 2007/031753 (22.03.2007 Gazette 2007/12) (54) Monophasic film-forming composition for topical administration Monophasische filmbildende Zusammensetzung zum topischen Auftrag Composition monophase formant un film pour l’administration à voie topique (84) Designated Contracting States: • JONES, Stuart, Allen AT BE BG CH CY CZ DE DK EE ES FI FR GB GR London SE3 0XA (GB) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR (74) Representative: Lord, Hilton David Marks & Clerk LLP (30) Priority: 14.09.2005 GB 0518769 90 Long Acre London (43) Date of publication of application: WC2E 9RA (GB) 18.06.2008 Bulletin 2008/25 (56) References cited: (73) Proprietor: Medpharm Limited WO-A2-01/43722 US-A- 4 752 466 Charlbury, US-A- 4 863 721 US-A1- 2004 184 994 Oxfordshire OX7 3RR (GB) US-A1- 2004 213 744 (72) Inventors: • BROWN, Marc, Barry Hertfordshire WD19 4QQ (GB) 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. -
1: Gastro-Intestinal System
1 1: GASTRO-INTESTINAL SYSTEM Antacids .......................................................... 1 Stimulant laxatives ...................................46 Compound alginate products .................. 3 Docuate sodium .......................................49 Simeticone ................................................... 4 Lactulose ....................................................50 Antimuscarinics .......................................... 5 Macrogols (polyethylene glycols) ..........51 Glycopyrronium .......................................13 Magnesium salts ........................................53 Hyoscine butylbromide ...........................16 Rectal products for constipation ..........55 Hyoscine hydrobromide .........................19 Products for haemorrhoids .................56 Propantheline ............................................21 Pancreatin ...................................................58 Orphenadrine ...........................................23 Prokinetics ..................................................24 Quick Clinical Guides: H2-receptor antagonists .......................27 Death rattle (noisy rattling breathing) 12 Proton pump inhibitors ........................30 Opioid-induced constipation .................42 Loperamide ................................................35 Bowel management in paraplegia Laxatives ......................................................38 and tetraplegia .....................................44 Ispaghula (Psyllium husk) ........................45 ANTACIDS Indications: -
Specialty Drug Benefit Document
Louisiana Healthcare Connections Specialty Drug Benefit ouisiana Healthcare Connections provides coverage of a number of specialty drugs. All specialty drugs, such as biopharmaceuticals and injectables, require a prior authorization (PA) to be approved for L payment by Louisiana Healthcare Connections. PA requirements are programmed specific to the drug. Since the list of specialty drugs changes over time due to new drug arrivals and other market conditions, it is important to contact Provider Services at 1-866-595-8133 or check the Louisiana Healthcare Connections website at www.LouisianaHealthConnect.com for updates to this benefit. Requests for specialty drugs can be submitted to Louisiana Healthcare Connections by filling out the Medication Prior Authorization Form that is available on the Louisiana Healthcare Connections website at www.LouisianaHealthConnect.com and faxing the request as instructed on the form. Louisiana Healthcare Connections members can receive the specialty drugs they require at any outpatient pharmacy enrolled in our pharmacy network that can supply specialty drugs. Providers that wish to have drugs distributed by a SPECIALTY PHARMACY should FAX the request to 1-866-399-0929 for review. If a provider wishes to dispense a specialty drug from OFFICE STOCK, the provider should FAX the request to Louisiana Healthcare Connections at 1-877-401-8172 for review. BRAND NAME INGREDIENTS SPECIAL INSTRUCTIONS ACTEMRA TOCILIZUMAB ACTHAR HP CORTICOTROPIN ACTIMMUNE INTERFERON GAMMA-1B ADAGEN PEGADEMASE BOVINE Limited Distribution