| OPPOSITION | - Allam Ahmed N, El Safaa S, Naggar Viviane F, "Bioavailability: A Pharmaceutical Review", Journal Novel Drug Delivery, (20110420), vol. 1, no. 1, pages 77 - 93, XP093269187 | - |
| OPPOSITION | - Allen Jr L V, Luner, P E, "Magnesium Stearate", Allen Jr L V, Luner, P E, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090203), pages 404 - 407, ISBN 978-0-85369-792-3, XP055956908 | - |
| OPPOSITION | - "ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - KOSELUGO (selumetinib)", SmPC, (20230101), pages 1 - 39, XP093270660 | - |
| OPPOSITION | - " ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - NEXAVAR", SmPC, (20110101), pages 1 - 34, XP093270662 | - |
| OPPOSITION | - "ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - TASIGNA", (20120101), pages 1 - 74, URL: https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf, XP093269233 | - |
| OPPOSITION | - "ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - TAVLESSE", (20200211), pages 1 - 37, URL: https://www.ema.europa.eu/en/documents/product-information/tavlesse-epar-product-information_en.pdf, XP093269221 | - |
| OPPOSITION | - " ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - XELJANZ ", (20170101), pages 1 - 44, XP093270665 | - |
| OPPOSITION | - Anonymous, "ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - ZELBORAF", SmPC, (20160101), pages 1 - 39, XP093270664 | - |
| OPPOSITION | - Anonymous, "Guideline on the investigation of drug interactions", European Medicines Agency (EMA), Internet, Internet , (20120621), pages 2 - 59, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf, (20200902), XP055727049 | - |
| OPPOSITION | - Bertram G. Katzung, "Chapter 1 Introduction", Basic & Clinical Pharmacology, US, McGraw-Hill Medical, (20120101), pages 1 - 13, ISBN 978-0-07-176402-5, XP009555923 | - |
| OPPOSITION | - D031 - SEPS PHARMA DEVELOPMENT REPORT | - |
| OPPOSITION | - D55 - T1989-19 (EN translation) | - |
| 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 | - Hapgood K P, "Colloidal Silicon Dioxide", Hapgood K P, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090203), pages 185 - 188, ISBN 978-0-85369-792-3, XP055959239 | - |
| OPPOSITION | - Keebler Daniel, Jones Nicholas, Mcenany Matthew, "Widespread Chronic Use of Proton-Pump Inhibitors and Potential for Drug-Drug Interactions in Rheumatoid Arthritis and Lupus Patients - Abstract 228", ABSTRACT SUPPLEMENT 2018 ACR/ARHP Annual Meeting, US, (20180901), vol. 70, no. 59, pages 1 - 2, XP093270681 | - |
| OPPOSITION | - Kibbe A H, "Starch, Pregelatinized", Kibbe A H, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090205), pages 691 - 694, ISBN 978-0-85369-792-3, XP093228174 | - |
| OPPOSITION | - Michael E. Aulton, Et Al., "Chapter 17: Bioavailability - physicochemical and dosage form factors", PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, Second Edition, Elsevier , (20020101), pages 234 - 252, ISBN 0-443-05517-3, XP055466214 | - |
| OPPOSITION | - Nicholas H. G. Holford, "Chapter 3: Pharmacokinetics & Pharmacodynamics: Rational Dosing & the Time Course of Drug Actio", Basic & Clinical Pharmacology, US, McGraw-Hill Medical, (20120101), pages 37 - 51, ISBN 978-0-07-176402-5, XP009555925 | - |
| OPPOSITION | - Rowe Raymond C, Et Al, "Cellulose, Microcrystalline", Rowe Raymond C, Et Al, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 129 - 133, ISBN 978-0-85369-792-3, XP055796468 | - |
| OPPOSITION | - Simon Gaisford, "Chapter 23 Pharmaceutical preformulation", Aulton's Pharmaceutics, Edinburgh, Elsevier, (20180101), pages 380 - 406, ISBN 978-0-7020-7003-7, XP009552583 | - |
| OPPOSITION | - von Zastrow, Mark, "Chapter 2: Drug Receptors / Pharmacodynamics", Basic & Clinical Pharmacology, US, McGraw-Hill Medical, (20120101), pages 15 - 35, ISBN 978-0-07-176401-8, XP009555924 | - |
| OPPOSITION | - Anderson K., H. Zheng, M. Kotecha, B. Scott, S. Sharma, T. Tarnowski, B. Kearney, Y. Xin, "PII-006 RELATIVE BIOAVAILABILITY, FOOD EFFECT AND INTERACTION WITH ACID REDUCING AGENTS OF FILGOTINIB TABLETS IN HEALTHY SUBJECTS", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20170201), vol. 101, no. S1, doi:10.1002/cpt.570, ISSN 0009-9236, pages S55 - S56, XP093220457 | |
| OPPOSITION | - Sherif I. Farag Badawy, Hussain Munir A., "Microenvironmental pH Modulation in Solid Dosage Forms", Journal of pharmaceutical sciences, Hoboken, (20070501), vol. 96, no. 5, doi:10.1002/jps.20932, ISSN 0022-3549, pages 948 - 959, XP055359872 | |
| OPPOSITION | - Timmins Peter, Pygall Samuel R., "Microenvironmental pH Control and Mixed Polymer Approaches to Optimise Drug Delivery with Hydrophilic Matrix Tablets", Hydrophilic Matrix Tablets for Oral Controlled Release, Springer New York, (20141011), vol. 16, pages 257 - 280, doi:10.1007/978-1-4939-1519-4_11, ISSN 2210-7371, ISBN 978-1-4939-1519-4, XP093228129 | |
| OPPOSITION | - Namour Florence, Diderichsen Paul Matthias, Cox Eugène, Vayssière Béatrice, Van Der Aa Annegret, Tasset Chantal, Van‘t Klooster Gerben, "Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20150801), vol. 54, no. 8, doi:10.1007/s40262-015-0240-z, ISSN 0312-5963, pages 859 - 874, XP093220442 | |
| OPPOSITION | - Thoma, K. ; Zimmer, T., "Retardation of weakly basic drugs with diffusion tablets", International Journal of Pharmaceutics, NL, (19900221), vol. 58, no. 3, doi:10.1016/0378-5173(90)90195-A, ISSN 0378-5173, pages 197 - 202, XP025568447 | |
| OPPOSITION | - Bloomer Jackie C.; Ambery Claire; Miller Bruce E.; Connolly Paul; Garden Helen; Henley Nick; Hodnett Neil; Keel Sarah; Kreindler James L.; Lloyd Richard S.; Matthews Wayne; Yonchuk John; Lazaar Aili L., "Identification and characterisation of a salt form of Danirixin with reduced pharmacokinetic variability in patient populations", European journal of pharmaceutics and biopharmaceutics, NL , (20170403), vol. 117, doi:10.1016/j.ejpb.2017.03.023, ISSN 0939-6411, pages 224 - 231, XP085093119 | |
| OPPOSITION | - Chika Taniguchi; Ryo Inoue; Yohei Kawabata; Kazuhiro Yamashita; Koichi Wada; Yukinori Yamauchi; Shizuo Yamada; Satomi Onoue;, "Novel formulations of dipyridamole with microenvironmental pH-modifiers for improved dissolution and bioavailability under hypochlorhydria", International Journal of Pharmaceutics, NL, (20120519), vol. 434, no. 1, doi:10.1016/j.ijpharm.2012.05.040, ISSN 0378-5173, pages 148 - 154, XP028428039 | |
| OPPOSITION | - Larsen, J. ; Cornett, C. ; Jaroszewski, J.W. ; Hansen, S.H., "Reaction between drug substances and pharmaceutical excipients: Formation of citric acid esters and amides of carvedilol in the solid state", Journal of Pharmaceutical and Biomedical Analysis, NL, (20090115), vol. 49, no. 1, doi:10.1016/j.jpba.2008.09.039, ISSN 0731-7085, pages 11 - 17, XP025881697 | |
| OPPOSITION | - Gumieniczek Anna; Berecka Anna; Mroczek Tomasz; Wojtanowski Krzysztof; Dąbrowska Kinga; Stępień Katarzyna, "Determination of chemical stability of sitagliptin by LC-UV, LC-MS and FT-IR methods", Journal of Pharmaceutical and Biomedical Analysis, NL, (19000101), vol. 164, doi:10.1016/j.jpba.2018.11.023, ISSN 0731-7085, pages 789 - 807, XP085556813 | |
| OPPOSITION | - O'donoghue Michelle L, Braunwald Eugene, Antman Elliott M, Murphy Sabina A, Bates Eric R, Rozenman Yoseph, Michelson Alan D, Hautvast Raymond W, Lee Ver, Close Sandra L, Shen Lei, Mega Jessica L, Sabatine Marc S, Wiviott Stephen D, "Pharmacodynamic eff ect and clinical effi cacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials", Lancet, (20090919), vol. 374, doi:10.1016/S0140-6736(09)6125-7, pages 989 - 997, XP093270697 | |
| OPPOSITION | - Mohan Shikhar, Li Yi, Chu Kevin, De La Paz Liliana, Sperger Diana, Shi Bing, Foti Chris, Rucker Victor, Lai Chiajen, "Integrative Salt Selection and Formulation Optimization: Perspectives of Disproportionation and Microenvironmental pH Modulation", Molecular Pharmaceutics, US , (20240506), vol. 21, no. 5, doi:10.1021/acs.molpharmaceut.4c00166, ISSN 1543-8384, pages 2590 - 2605, XP093269070 | |
| OPPOSITION | - Morrison Henry, Fung Peter, Horstman Elizabeth, Lapina Olga, Khuth Thoeun, Lye Diane S., Regens Christopher S., Bringley Dustin, Alleva Jennifer, "Application of Twin Screw Extrusion to Scale Polymorphs, a Salt, and the Amorphous Phase for Various Drug Substances", Organic Process Research & Development, US , (20240419), vol. 28, no. 4, doi:10.1021/acs.oprd.4c00010, ISSN 1083-6160, pages 1186 - 1194, XP093269078 | |
| OPPOSITION | - Christel J. Menet, Fletcher Stephen R, Lommen Guy Van, Geney Raphael, Blanc Javier, Smits Koen, Jouannigot Nolwenn, Deprez Pierre, Van Der Aar Ellen M, Clement-Lacroix Philippe, Lepescheux Liê N, Renealien, Vayssiere Beátrice, Nelles Luc, Christophe Thierry, Brys Reginald, Uhring Muriel, Ciesielski Fabrice, ∥, Rompaey Luc Van, "Triazolopyridines as Selective JAK1 Inhibitors: From Hit Identification to GLPG0634", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20141126), vol. 57, no. 22, doi:10.1021/jm501262q, ISSN 0022-2623, pages 9323 - 9342, XP055272599 | |
| OPPOSITION | - Stella Valentino J., Rao Venkatramana M., Martodihardjo Suwaldi, "Aqueous solubility and dissolution rate does not adequately predict in vivo performance: A probe utilizing some N‐acyloxymethyl phenytoin prodrugs", Journal of pharmaceutical sciences, (19990801), vol. 88, no. 8, doi:10.1021/js980489i, ISSN 0022-3549, pages 775 - 779, XP093269193 | |
| OPPOSITION | - Amitava Mitra, Filippos Kesisoglou, "Impaired Drug Absorption Due to High Stomach pH: A Review of Strategies for Mitigation of Such Effect To Enable Pharmaceutical Product Development", Molecular Pharmaceutics, American Chemical Society, US, US , (20131104), vol. 10, no. 11, doi:10.1021/mp400256h, ISSN 1543-8384, pages 3970 - 3979, XP055368085 | |
| OPPOSITION | - Mark M. Menning, Sean M. Dalziel, "Fumaric Acid Microenvironment Tablet Formulation and Process Development for Crystalline Cenicriviroc Mesylate, a BCS IV Compound", Molecular Pharmaceutics, American Chemical Society, US, US , (20131104), vol. 10, no. 11, doi:10.1021/mp400286s, ISSN 1543-8384, pages 4005 - 4015, XP055295392 | |
| OPPOSITION | - Smelick Gillian S., Heffron Timothy P., Chu Laura, Dean Brian, West David A., Duvall Scott L., Lum Bert L., Budha Nageshwar, Holden Scott N., Benet Leslie Z., Frymoyer Adam, Dresser Mark J., Ware Joseph A., "Prevalence of Acid-Reducing Agents (ARA) in Cancer Populations and ARA Drug-Drug Interaction Potential for Molecular Targeted Agents in Clinical Development", Molecular Pharmaceutics, American Chemical Society, US, US , (20131104), vol. 10, no. 11, doi:10.1021/mp400403s, ISSN 1543-8384, pages 4055 - 4062, XP093220468 | |
| OPPOSITION | - Mathias Neil R., Xu Yan, Patel Dhaval, Grass Michael, Caldwell Brett, Jager Casey, Mullin Jim, Hansen Luke, Crison John, Saari Amy, Gesenberg Christoph, Morrison John, Vig Balvinder, Raghavan Krishnaswamy, "Assessing the Risk of pH-Dependent Absorption for New Molecular Entities: A Novel in Vitro Dissolution Test, Physicochemical Analysis, and Risk Assessment Strategy", Molecular Pharmaceutics, US, (20131104), vol. 10, no. 11, doi:10.1021/mp400426f, ISSN 1543-8384, pages 4063 - 4073, XP093269197 | |
| OPPOSITION | - Ware Joseph A., Dalziel Gena, Jin Jin Y., Pellett Jackson D., Smelick Gillian S., West David A., Salphati Laurent, Ding Xiao, Sutton Rebecca, Fridyland Jane, Dresser Mark J., Morrisson Glenn, Holden Scott N., "Impact of Food and the Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of GDC-0941 in Healthy Volunteers: Bench to Bedside Investigation of pH-Dependent Solubility", Molecular Pharmaceutics, American Chemical Society, US, US , (20131104), vol. 10, no. 11, doi:10.1021/mp4005595, ISSN 1543-8384, pages 4074 - 4081, XP093220466 | |
| OPPOSITION | - Ware Joseph A., Dalziel Gena, "Physical Chemical Drug-Drug Interactions from Drug Discovery to Registration: New Opportunities for the Pharmaceutical Scientist To Impact Drug Development", Molecular Pharmaceutics, American Chemical Society, US, US , (20131104), vol. 10, no. 11, doi:10.1021/mp4005639, ISSN 1543-8384, pages 3967 - 3969, XP093220465 | |
| OPPOSITION | - Seiler Dan, Doser Karlheinz ; Salem Isam, "Relative bioavailability of prasugrel free base in comparison to prasugrel hydrochloride in the presence and in the absence of a proton pump inhibitor", Arzneimittelforschung, (20110101), vol. 61, no. 4, doi:10.1055/s-0031-1296195, pages 247 - 251, XP093270692 | |
| OPPOSITION | - E. LAHNER; B. ANNIBALE; G. DELLE FAVE, "Systematic review: impaired drug absorption related to the co‐administration of antisecretory therapy", Alimentary Pharmacology & Therapeutics, BLACKWELL SCIENTIFIC PUBLICATIONS LTD., CAMBRIDGE., GB, GB , (20090306), vol. 29, no. 12, doi:10.1111/j.1365-2036.2009.03993.x, ISSN 0269-2813, pages 1219 - 1229, XP071541038 | |
| OPPOSITION | - Westhovens R, Taylor P C, Alten R, Pavlova D, Enríquez-Sosa F, Mazur M, Greenwald M, Van Der Aa A, Vanhoutte F, Tasset C, Harrison P, "Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1)", Annals of the Rheumatic Diseases, GB, (20170601), vol. 76, no. 6, doi:10.1136/annrheumdis-2016-210104, ISSN 0003-4967, pages 998 - 1008, XP055846617 | |
| OPPOSITION | - Small David S., Farid Nagy A., Payne Christopher D., Weerakkody Govinda J., Li Ying G., Brandt John T., Salazar Daniel E., Winters Kenneth J., "Effects of the Proton Pump Inhibitor Lansoprazole on the Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel", The Journal of clinical pharmacology, US , (20080401), vol. 48, no. 4, doi:10.1177/0091270008315310, ISSN 0091-2700, pages 475 - 484, XP093270694 | |
| OPPOSITION | - Bassi Pallavi, Kaur Gurpreet, "pH modulation: a mechanism to obtain pH-independent drug release", Expert Opinion on Drug Delivery, Informa Healthcare, GB, GB , (20100701), vol. 7, no. 7, doi:10.1517/17425247.2010.491508, ISSN 1742-5247, pages 845 - 857, XP093220314 | |
| OPPOSITION | - Chika Taniguchi, Yohei Kawabata, Koichi Wada, Shizuo Yamada, Satomi Onoue, "Microenvironmental pH-modification to improve dissolution behavior and oral absorption for drugs with pH-dependent solubility", Expert Opinion on Drug Delivery, Informa Healthcare, GB, GB , (20140401), vol. 11, no. 4, doi:10.1517/17425247.2014.881798, ISSN 1742-5247, pages 505 - 516, XP055753676 | |
| OPPOSITION | - Namour Florence, Desrivot Julie, Van Der Aa Annegret, Harrison Pille, Tasset Chantal, Van't Klooster Gerben, "Clinical Confirmation that the Selective JAK1 Inhibitor Filgotinib (GLPG0634) has a Low Liability for Drug-drug Interactions", Drug Metabolism Letters, (20160212), vol. 10, no. 1, doi:10.2174/1872312810666151223103353, ISSN 1872-3128, pages 38 - 48, XP093220446 | |
| OPPOSITION | - Deepak Gupta, Deepak Bhatia, Vivek Dave, Vijaykumar Sutariya, Sheeba Varghese Gupta, "Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations", Molecules, (20180714), vol. 23, no. 7, doi:10.3390/molecules23071719, page 1719, XP055718934 | |
| OPPOSITION | - Lee Sung-Hoon, Lee Sung-Hoon, "Immediate Drug Release Enhancement of Nateglinide Using Fumaric Acid", Journal of the Korea Academia-Industrial cooperation Society, (20170131), vol. 18, no. 1, doi:10.5762/KAIS.2017.18.1.506, ISSN 1975-4701, pages 506 - 512, XP093228133 | |
