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Pharmaceutical Formulations Comprising 4-{(1 R)-2-[(6-{2-[(2,6-Dichlorobenzyl)Oxy]Ethoxy}Hexyl)Amino]-1-Hydroxyethyl}-2-(Hydroxymethyl)Phenol - EP3578169

The patent EP3578169 was granted to Glaxo Group on Jun 26, 2024. The application was originally filed on Feb 26, 2009 under application number EP19175120A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3578169

GLAXO GROUP
Application Number
EP19175120A
Filing Date
Feb 26, 2009
Status
Granted And Under Opposition
May 24, 2024
Grant Date
Jun 26, 2024
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (4)

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ELKINGTON AND FIFEMar 26, 2025ELKINGTON AND FIFEADMISSIBLE
TEVA PHARMACEUTICALSMar 26, 2025ELKINGTON AND FIFEADMISSIBLE
AERAMar 24, 2025BARDEHLE PAGENBERG SLADMISSIBLE
SANDOZJun 27, 2024MAIWALDADMISSIBLE

Patent Citations (29) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication Number
DESCRIPTIONGB2242134
DESCRIPTIONWO0212265
DESCRIPTIONWO03024439
DESCRIPTIONWO03061743
DESCRIPTIONWO2007012871
DESCRIPTIONWO2007068896
EXAMINATIONWO2008021142
OPPOSITIONUS2006239932
OPPOSITIONUS2007212422
OPPOSITIONUS2008003290
OPPOSITIONUS7439393
OPPOSITIONWO0028979
OPPOSITIONWO0212265
OPPOSITIONWO0212266
OPPOSITIONWO03024439
OPPOSITIONWO03061743
OPPOSITIONWO2005004845
OPPOSITIONWO2006008173
OPPOSITIONWO2006108572
OPPOSITIONWO2006124556
OPPOSITIONWO2007109698
OPPOSITIONWO2007117911
OPPOSITIONWO2007135024
OPPOSITIONWO2008021142
OPPOSITIONWO2008049842
SEARCHUS2006239932
SEARCHUS2008003290
SEARCHWO03061743
SEARCHWO2007117911

Non-Patent Literature (NPL) Citations (106) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference Text
EXAMINATION- NICOLA A. HANANIA ET AL, "The Efficacy and Safety of the Novel Long-Acting beta2 Agonist Vilanterol in Patients With COPD - A Randomized Placebo-Controlled Trial", CHEST, (20120701), vol. 142, no. 1, doi:10.1378/chest.11-2231, pages 119 - 127, XP055214172
OPPOSITION- Allen, Popovich, Ansel, "New drug development and approval process", Allen, Popovich, Ansel, Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C., [Pharmaceutical dosage forms and drug delivery systems] Ansel's pharmaceutical dosage forms and drug delivery systems, US , Lippincott Williams & Wilkins , (20050101), pages 25 - 203, ISBN 0-7817-4612-4, XP055695463
OPPOSITION- Anonymous, "3.1.1.1 Seelective beta2, agonists", BRITISH NATIONAL FORMULARY, LONDON, GB, GB , (20080901), vol. 56, ISSN 0260-535X, pages 151 - 155, XP009561481
OPPOSITION- Anonymous, "ANNEX I - SUMMARY OF PRODUCT CHARACTERISTICS - Relvar Ellipta", (20180726), pages 1 - 74, URL: https://www.ema.europa.eu/en/documents/product-information/relvar-ellipta-epar-product-information_en.pdf, (20210324), XP055789754
OPPOSITION- Anonymous, "A Randomised, Single-dose, Dose Ascending, Double-blind, Placebo Controlled, Four-way, Incomplete Block Crossover St Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magn Stearate in COPD Patients", Clinicaltrials.gov - Study NCT00519376, (20081009), Clinicaltrials.gov - Study NCT00519376, URL: https://clinicaltrials.gov/ct2/history/NCT00519376?V_3=View#StudyPageTop, (20200514), XP055695414
OPPOSITION- Anonymous, "A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asth Patients", Clinicaltrials.gov - Study NCT00463697, (20081015), Clinicaltrials.gov - Study NCT00463697, URL: https://clinicaltrials.gov/ct2/history/NCT00463697?V_5=View#StudyPageTop, (20200514), XP055695478
OPPOSITION- Anonymous, "A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)", ClinicalTrials.gov Identifier: NCT00606684, (20161216), ClinicalTrials.gov Identifier: NCT00606684, (20200514), XP055695558
OPPOSITION- Anonymous, "A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)", US National Library of Medicine Clinicaltrails.gov, Clinicaltrials, (20080204), pages 1 - 14, US National Library of Medicine Clinicaltrails.gov, URL: https://clinicaltrials.gov/ct2/show/record/NCT00606684?draw=2, (20200420), XP055687488
OPPOSITION- Anonymous, "Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma", ClinicalTrials.gov Identifier: NCT00600171, (20161216), ClinicalTrials.gov Identifier: NCT00600171, (20200515), XP055695737
OPPOSITION- Anonymous, "Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma", History of Changes for Study: NCT00600171, (20090122), History of Changes for Study: NCT00600171, URL: https://clinicaltrials.gov/ct2/show/NCT00600171, (20200514), XP055695564
OPPOSITION- Anonymous, "Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma full report 2007", Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma full report 2007, national heart, lung and blood institute, (20070101), pages 1 - 72, XP055687517
OPPOSITION- Anonymous, "GSK and Theravance announce positive phase 2b results for LABA `444 in the treatment of COPD in the Horizon Development Programme", (20081222), XP093269084
OPPOSITION- Anonymous, "Guideline for Industry Dose-Response Information to Support Drug Registration ICH-E4", FDA, (19941101), FDA, URL: https://www.fda.gov/media/71279/download, XP093269015
OPPOSITION- Anonymous, "History of Changes for Study: NCT00731822 A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COP)", ClinicalTrials.gov Identifier: NCT00731822, (20080808), ClinicalTrials.gov Identifier: NCT00731822, (20200515), XP055695736
OPPOSITION- Anonymous, "ICH Topic E 4, DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION", Emea, (19941101), pages 1 - 10, XP093257632
OPPOSITION- Anonymous, "Study B2C111045, A Dose-Finding Study of GW642444 Versus Placebo in Patients With COPD", Clinicaltrials.gov - Study NCT00606684, (20081106), Clinicaltrials.gov - Study NCT00606684, URL: https://clinicaltrials.gov/ct2/history/NCT00606684?V_11=View#StudyPageTop, (20200514), XP055695390
OPPOSITION- Anonymous, "Study Details Tabular View Study Results Disclaimer How to Read a Study Record A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)", ClinicalTrials.gov Identifier: NCT00731822, (20161208), ClinicalTrials.gov Identifier: NCT00731822, (20200515), XP055695735
OPPOSITION- Anonymous, "Theravance, Inc. Announces Positive Results of Clinical Program in Beyond Advair Collaboration", Biospace, (20070402), pages 1 - 5, Biospace, URL: https://www.biospace.com/article/releases/theravance-inc-announces-positive-results-of-clinical-program-in-beyond-advair-collaboration-/, (20200420), XP055687523
OPPOSITION- Anonymous, "USP 31 / NF 26", US Pharmacopeia, (20080501), vol. 1, pages 605 - 607, XP055697910
OPPOSITION- Anonymus, "Drugs for the treatment of respiratory diseases", Cambridge University Press, (20030101), XP055697915
OPPOSITION- Anonymus, "GlaxoSmithKline and Theravance, Inc. Announce Positive Phase 2b Results For Once-Daily Fluticasone Furoate In The Treatment Of Asthma", (20090204), (20200513), XP055694873
OPPOSITION- Anonymus, "GLOBAL INITIATIVE FOR ASTHMA", Global Strategy for Asthma Management and Prevention, (20080101), XP055697857
OPPOSITION- Anonymus, "Global initiative for chronic obstructive lung disease for chronic obstructive pulmonary disease", GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE (GOLD), (20060101), XP055697851
OPPOSITION- B Anonymous, "A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients", Clinicaltrials.gov - Study NCT00463697, (20100715), Clinicaltrials.gov - Study NCT00463697, (20200514), XP055695474
OPPOSITION- BARNES P J, "ABC OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE: FUTURE TREATMENTS", BMJ. BRITISH MEDICAL JOURNAL., LONDON, GB, GB , (20060729), vol. 333, no. 7561, ISSN 0959-8146, pages 246 - 248, XP009083676
OPPOSITION- B. Mei Jin Tanm L. Wah Chan and P. Wan Sia Heng, "Chapter 11: Milling and Blending: Producing the Right Particles and Blend Characeristics for Dry Powder Inhalation", B. Mei Jin Tanm L. Wah Chan and P. Wan Sia Heng, Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, Third Edition, CRC Press, (20190101), pages 273 - 290, ISBN 9781138063075, XP009560595
OPPOSITION- Calisha Myers, "GSK and Teravance announce positive phase 2b results for LABA, '444 in the Horizon Asthma Development Programme", FierceBiotech, (20081202), FierceBiotech, URL: https://www.fiercebiotech.com/biotech/gsk-and-theravance-announce-positive-phase-2b-results-for-laba-444-horizon-asthma, (20200513), XP055694882
OPPOSITION- Cbip, "REPERTOIRE COMMENTE DES MEDICAMENTS 2008", CENTRE BELGE D'INFORMATION PHARMACOTHERAPEUTIQUE, (20080101), CENTRE BELGE D'INFORMATION PHARMACOTHERAPEUTIQUE, URL: https://www.cbip.be/ggr_pdfs/GGR_FR_2008.pdf, (20200514), XP055695496
OPPOSITION- D100 - Board of Appeal decision T2015/20
OPPOSITION- D101 - Decision of the Opposition Division dated April 13, 2016 in respect of EP 1 931 350
OPPOSITION- D102 - NCT00702910.1
OPPOSITION- D103 - NCT00469040.1
OPPOSITION- D105 - Decision to Refuse from the Examining Division in a divisional application of the patent leading to T 7/07
OPPOSITION- D106 - Minutes of the oral proceedings before the board of appeal hearing theappeal resulting from the refusal in D105
OPPOSITION- D107 - Print-out of a webpage of the National Institute on Aging
OPPOSITION- D108 - FDA Guidance for Industry (1997): General Considerations for the Clinical Evaluation of Drugs
OPPOSITION- D110 - D102 T0237/15
OPPOSITION- D114 - Decision T 1409/06
OPPOSITION- D116 - Declaration by Prof. Alf Lamprecht dated 12 February 2024
OPPOSITION- D117a - Federal Register, Vol. 72, No. 217, Friday, November 9, 2007, Notices
OPPOSITION- D122 - Interlocutory decision dated 14 May 2024 in the opposition proceedings relating to the parent patent EP 2 400 950
OPPOSITION- D19 - October 2008 version of the Helsinki Declaration
OPPOSITION- D1 - Submissions of the Proprietor in the examination proceedings related to the opposed patent dated 4 February 2013.
OPPOSITION- D20 - Decision T 7/07 of 7 July 2011
OPPOSITION- D21 - Decision T 239/16 of 13 September 2017
OPPOSITION- D27 - D5 T950/13
OPPOSITION- D31 - T712/13
OPPOSITION- D36 - Actavis & Ors v ICOS & Or [2017] EWCA Civ 1671
OPPOSITION- D37 - Actavis Group PTC EHF and others v ICOS Corporation and another [2019] UKSC 15
OPPOSITION- D38 - T1753/06
OPPOSITION- D39a - Curriculum Vitae of Mr Gary Muirhead
OPPOSITION- D39 - Expert declaration provided by Mr Gary Muirhead
OPPOSITION- D54 - Patentee’s letter dated 14 March 2016
OPPOSITION- D55 - print-out from https://clinicaltrials.gov/ct2/show/NCT01147848, version dated 18 January 2017
OPPOSITION- D58a - Study B2C111045 A Dose-Finding Study of GW 642444 versus Placebo in Patients with COPD
OPPOSITION- D58 - print-out from https://www.gsk-studyregister.com/study?uniqueStudyId=B2C111045
OPPOSITION- D61 - print-out from https://www.gsk-studyregister.com/study?uniqueStudyId=B2C109575
OPPOSITION- D64 - print-out from https://www.gsk-studyregister.com/study?uniqueStudyId=HZC111348
OPPOSITION- D82 - USAN information vilanterol and vilanterol trifenatate (downloaded on 13 February 2020)
OPPOSITION- D83 - USAN information fluticasone furoate (downloaded on 13 February 2020)
OPPOSITION- D88 - Definition of the term “respiratory disease” downloaded on 12 February 2020 from the online NCI Dictionary of Cancer Terms https://www.cancer.gov/publications/dictionaries/cancerterms/def/r espiratory-disease
OPPOSITION- D89 - USAN for vilanterol
OPPOSITION- D90 - USAN for vilanterol trifenatate
OPPOSITION- D92 - BNF for indacaterol
OPPOSITION- D94 - EPAR for ANORO ELLIPTA
OPPOSITION- D95 - EPAR for TRELEGY ELLIPTA
OPPOSITION- D96 - Decision T 79916
OPPOSITION- D98 - Informed Consent Form relating to clinical trial in D28/D29 USAN for vilanterol
OPPOSITION- Edge S., Ah Kibbe, J Shur, "Lactose, Monohydrate", Edge S., Ah Kibbe, J Shur, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090310), pages 364 - 369, ISBN 978-0-85369-792-3, XP093228149
OPPOSITION- Emea, "Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma", CPMP/EWP/2922/01, (20021121), CPMP/EWP/2922/01, URL: https://www.ema.europa.eu, (20200514), XP055695506
OPPOSITION- Fda, "Guidance for Industry Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment ", DRAFT GUIDANCE, U.S. Department of Health and Human Services, (20071101), DRAFT GUIDANCE, XP093166733
OPPOSITION- Glaxosmithkline, "A Study To Assess Ecacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD) - NCT00606684", Clinical Trials, Clinicaltrials.gov, (20080201), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT00606684?term=NCT00606684&rank=1&tab=history&a=1#version-content-panel, XP093269004
OPPOSITION- Glaxosmithkline, "Safety and Ecacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma - NCT00766090", Clinical Trials, Clinicaltrials.gov, (20081002), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT00766090?term=NCT00766090&rank=1&tab=history&a=1#version-content-panel, XP093269000
OPPOSITION- Jagdeep Shur ; Haggis Harris ; Matthew D. Jones ; J. Sebastian Kaerger ; Robert Price, "The Role of Fines in the Modification of the Fluidization and Dispersion Mechanism Within Dry Powder Inhaler Formulations", Pharmaceutical Research, Kluwer Academic Publishers-Plenum Publishers, NL, NL , (20080201), vol. 25, no. 7, ISSN 1573-904X, pages 1631 - 1640, XP019613105
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OPPOSITION- Michael W. Aguiar, "Theravance Reports Fourth Quarter and Full Year 2008 Results", Theravance, (20090212), Theravance, URL: http://investor.inva.com/static-files/9fd7587e-8c26-4555-813f-d4708a4cb984, (20200514), XP055695513
OPPOSITION- R. Kempsford, Et Al, "GW642444, a Novel Inhaled Long-acting Beta2 Adrenoceptor Agonist (LABA), At Single Doses Of 25, 50 And 100mcg, Is Well Tolerated And Demonstrates Prolonged Bronchodilation In Asthmatic Patients", American Journal of Respiratory and Critical Care Medicine, (20100101), page A5413, American Journal of Respiratory and Critical Care Medicine, URL: https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2010.181.1_MeetingAbstracts.A5413, (20200514), XP055695470
OPPOSITION- Rowland, Malcolm ; Tozer, Thomas N., "7. Multiple-Dose Regimens", Rowland, Malcolm ; Tozer, Thomas N., Malcolm Rowland, Thomas N. Tozer, Clinical pharmacokinetics : concepts and applications , 3rd Edition, Williams & Wilkins, (19950101), pages 83 - 108, ISBN 0-683-07404-0, XP009560594
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OPPOSITION- Stephen P Newman, "JOURNAL OF AEROSOL MEDICINE How Well Do In Vitro Particle Size Measurements Predict Drug Delivery In Vivo?", JOURNAL OF AEROSOL MEDICINE, (19980101), vol. 11, no. S1, pages S97 - S104, XP055695567
OPPOSITION- W. • Hildebrand, "8 Klinische Prüfung von Arzneimitteln", Lehrbuch der Klinischen Pharmazie, Stuttgart,, Wissenschaftliche Verlagsgesellschaft, (19980101), pages 103 - 114, XP093166739
OPPOSITION- Xian Ming Zeng, Gary Peter Martin, Christopher Marriott, "5 Particulate Interactions in Dry Powder Aerosols", Xian Ming Zeng, Gary Peter Martin, Christopher Marriott, Xian Ming Zeng, Gary P. Martin, Christopher Marriott, Particulate interactions in dry powder formulations for inhalation, UK, Taylor & Francis, (20010101), pages 133 - 173, ISBN 9780429217821, XP009560578
OPPOSITION- Xian Ming Zeng, Gary P. Martin, Christopher Marriott, Particulate interactions in dry powder formulations for inhalation, Taylor & Francis, (2001), pages 155 - 159
OPPOSITION- Nazrul Islam, Peter Stewart, Ian Larson, Patrick Hartley, "Effect of carrier size on the dispersion of salmeterol xinafoate from interactive mixtures", Journal of Pharmaceutical Sciences, (20040400), vol. 93, no. 4, doi:10.1002/jps.10583, pages 1030 - 1038, XP055695571
OPPOSITION- Olof Selroos, "Formoterol Turbuhaler® 4.5μg (Delivered Dose) has a Rapid Onset and 12-h Duration of Bronchodilation", Pulmornary Pharmacology & Therapeutics, Academic Press, GB, GB , (20020501), vol. 15, no. 2, doi:10.1006/pupt.2001.0335, ISSN 1094-5539, pages 175 - 183, XP093166727
OPPOSITION- Tingting Peng, Lin Shiqi, Niu Boyi, Wang Xinyi, Huang Ying, Zhang Xuejuan, Li Ge, Pan Xin, Wu Chuanbin, "Influence of physical properties of carrier on the performance of dry powder inhalers", Acta Pharmaceutica Sinica B, Elsevier, (20160701), vol. 6, no. 4, doi:10.1016/j.apsb.2016.03.011, ISSN 2211-3835, pages 308 - 318, XP055695568
OPPOSITION- Canning, B.J. ; Chou, Y., "Using guinea pigs in studies relevant to asthma and COPD", Pulmornary Pharmacology & Therapeutics, Academic Press, GB, GB , (20081001), vol. 21, no. 5, doi:10.1016/j.pupt.2008.01.004, ISSN 1094-5539, pages 702 - 720, XP025349185
OPPOSITION- Ringdal N., Derom E., Wåhlin-Boll E., Pauwels R., "Onset and duration of action of single doses of formoterol inhaled via turbuhaler®", Respiratory Medicine, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (19980801), vol. 92, no. 8, doi:10.1016/S0954-6111(98)90348-1, ISSN 0954-6111, pages 1017 - 1021, XP093269097
OPPOSITION- M Cazzola, M G Matera, "Novel long-acting bronchodilators for COPD and asthma", British Journal of Pharmacology, Nature Pub. Group, etc., (20081001), vol. 155, no. 3, doi:10.1038/bjp.2008.284, ISSN 00071188, pages 291 - 299, XP055104106
OPPOSITION- Petr Pohunek, "Dose‐related efficacy and safety of formoterol (Oxis ® ) Turbuhaler ® compared with salmeterol Diskhaler ® in children with asthma", Pediatric Allergy and Immunology, Wiley-Blackwell Publishing Ltd., GB, GB , (20040201), vol. 15, no. 1, doi:10.1046/j.0905-6157.2003.00096.x, ISSN 0905-6157, pages 32 - 39, XP093166741
OPPOSITION- S.P. Newman, W.W. Busse, "Evolution of dry powder inhaler design, formulation, and performance", Respiratory Medicine, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20020501), vol. 96, no. 5, doi:10.1053/rmed.2001.1276, ISSN 0954-6111, pages 293 - 304, XP055695240
OPPOSITION- J Donohue, "Minimal clinically important differences in COPD lung function.", COPD Journal of Chronic Obstructive Pulmonary Disease, doi:10.1081/COPD-200053377, (20090824), pages 111 - 124, COPD Journal of Chronic Obstructive Pulmonary Disease, URL: https://www.tandfonline.com/doi/abs/10.1081/COPD-200053377?journalCode=icop20, (20200420), XP055687530
OPPOSITION- Ball D.I., Brittain R.T., Coleman R.A., Denyer L.H., Jack D., Johnson M., Lunts L.H.C., Nials A.T., Sheldrick K.E., Skidmore I.F., "Salmeterol, a novel, long‐acting β 2 ‐adrenoceptor agonist: characterization of pharmacological activity in vitro and in vivo", British journal of pharmacology, Wiley-Blackwell, UK, UK , (19911101), vol. 104, no. 3, doi:10.1111/j.1476-5381.1991.tb12486.x, ISSN 0007-1188, pages 665 - 671, XP093257496
OPPOSITION- Steven J Charlton, "Agonist efficacy and receptor desensitization: from partial truths to a fuller picture", British journal of pharmacology, Wiley-Blackwell, UK, UK , (20090901), vol. 158, no. 1, doi:10.1111/j.1476-5381.2009.00352.x, ISSN 0007-1188, pages 165 - 168, XP055695488
OPPOSITION- H. Chrystyn, "The DiskusTM: a review of its position among dry powder inhaler devices", International Journal of Clinical Practice, (20070601), vol. 61, no. 6, doi:10.1111/j.1742-1241.2007.01382.x, pages 1022 - 1036, XP055253686
OPPOSITION- R Kempsford, "The pharmacodynamics, pharmacokinetics and tolerability of repeat doses of the novel inhaled long-acting beta2 adrenoceptor agonist (LABA) GW642444 (25, 50 and 100 mcg) in healthy subjects", Am J Respir Crit Care Med, (20100101), vol. 181, doi:10.1164/ajrccm-conference.2010.181.1_MeetingAbstracts.A4461, XP055697897
OPPOSITION- M. Cazzola, M. G. Matera, "Emerging inhaled bronchodilators: an update", European Respiratory Journal, European Respiratory Society, (20090901), vol. 34, no. 3, doi:10.1183/09031936.00013109, ISSN 0903-1936, pages 757 - 769, XP055697899
OPPOSITION- J. Lotvall, E. D. Bateman, E. R. Bleecker, W. W. Busse, A. Woodcock, R. Follows, J. Lim, S. Stone, L. Jacques, B. Haumann, "24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids", European Respiratory Journal, Published jointly by the Society and Munksgaard, (20120901), vol. 40, no. 3, doi:10.1183/09031936.00121411, ISSN 09031936, pages 570 - 579, XP055213152
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OPPOSITION- Bianca Beilmann, René Kubiak, Peter Grab, Heribert Häusler, Peter Langguth, "Effect of interactive ternary mixtures on dispersion characteristics of ipratropium bromide in dry powder inhaler formulations", AAPS PharmSciTech, (20070601), vol. 8, no. 2, doi:10.1208/pt0802031, pages E32 - E39, XP055695509
OPPOSITION- Lee Sau Lawrence; Adams Wallace P.; Li Bing V.; Conner Dale P.; Chowdhury Badrul A.; Yu Lawrence X., "In VitroConsiderations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases", The AAPS Journal, Springer US, Boston, Boston , (20090603), vol. 11, no. 3, doi:10.1208/s12248-009-9121-4, pages 414 - 423, XP035719039
OPPOSITION- V. N. P. Le; T. H. Hoang Thi; E. Robins; M. P. Flament, "Dry Powder Inhalers: Study of the Parameters Influencing Adhesion and Dispersion of Fluticasone Propionate", AAPS PHARMSCITECH, Springer New York LLC, US, US , (20120308), vol. 13, no. 2, doi:10.1208/s12249-012-9765-8, ISSN 1530-9932, pages 477 - 484, XP035064294
OPPOSITION- Nicola A. Hanania, Et Al, "The Efficacy and Safety of the Novel Long-Acting beta2 Agonist Vilanterol in Patients With COPD - A Randomized Placebo-Controlled Trial", CHEST, (20120701), vol. 142, no. 1, doi:10.1378/chest.11-2231, pages 119 - 127, XP055214172
OPPOSITION- CAZZOLA M, ET AL, "Ultra long-acting beta2-agonists in development for asthma and chronic obstructive pulmonary disease", Expert Opinion on Investigational Drugs, Informa Healthcare, UK, UK , (20050701), vol. 14, no. 7, doi:10.1517/13543784.14.7.775, ISSN 1354-3784, pages 775 - 783, XP003026042
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