Anouk Donners

177 General Discussion 64. El Amrani M, Donners AAM, Hack CE, Huitema ADR, van Maarseveen EM. Six-step workflow for the quantification of therapeutic monoclonal antibodies in biological matrices with liquid chromatography mass spectrometry - A tutorial. Anal Chim Acta. 2019; 1080: 22-34. 65. Partridge MA, Purushothama S, Elango C, Lu Y. Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies. J Immunol Res. 2016; 2016: 6262383. 66. Tighe PJ, Ryder RR, Todd I, Fairclough LC. ELISA in the multiplex era: potentials and pitfalls. Proteomics Clin Appl. 2015; 9: 406-422. 67. Lim CY, In J. Considerations for crossover design in clinical study. Korean J Anesthesiol. 2021; 74: 293-299. 68. Hahn S. Understanding noninferiority trials. Korean J Pediatr. 2012; 55: 403-407. 69. Committee for Proprietary Medicinal P. Points to consider on switching between superiority and noninferiority. Br J Clin Pharmacol. 2001; 52: 223-228. 70. CDM_Working_Group. OMOP Common Data Model. Accessed on 08-01-2023. 71. Kotecha D, Asselbergs FW, Achenbach S, Anker SD, Atar D, Baigent C, Banerjee A, Beger B, Brobert G, Casadei B, Ceccarelli C, Cowie MR, Crea F, Cronin M, Denaxas S, Derix A, Fitzsimons D, Fredriksson M, Gale CP, Gkoutos GV, Goettsch W, Hemingway H, Ingvar M, Jonas A, Kazmierski R, Logstrup S, Lumbers RT, Luscher TF, McGreavy P, Pina IL, Roessig L, Steinbeisser C, Sundgren M, Tyl B, van Thiel G, van Bochove K, Vardas PE, Villanueva T, Vrana M, Weber W, Weidinger F, Windecker S, Wood A, Grobbee DE, Innovative Medicines Initiative BigData@Heart Consortium ESoCC-EHRicg. CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research. BMJ. 2022; 378: e069048. 72. Overhage JM, Ryan PB, Reich CG, Hartzema AG, Stang PE. Validation of a common data model for active safety surveillance research. J Am Med Inform Assoc. 2012; 19: 54-60. 73. Biedermann P, Ong R, Davydov A, Orlova A, Solovyev P, Sun H, Wetherill G, Brand M, Didden EM. Standardizing registry data to the OMOP Common Data Model: experience from three pulmonary hypertension databases. BMC Med Res Methodol. 2021; 21: 238. 74. McCrabb S, Mooney K, Elton B, Grady A, Yoong SL, Wolfenden L. How to optimise public health interventions: a scoping review of guidance from optimisation process frameworks. BMC Public Health. 2020; 20: 1849. 75. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A, Taylor SJ, Sta RIG. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017; 356: i6795. 76. Heled Y, Rutschman AS, Vertinsky L. The problem with relying on profit-driven models to produce pandemic drugs. J Law Biosci. 2020; 7: lsaa060. 77. Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL. How to improve R&D productivity: the pharmaceutical industry’s grand challenge. Nat Rev Drug Discov. 2010; 9: 203-214. 78. Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020; 323: 844-853. 9