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Malikova M.A. 35th Annual Europe Meeting, Drug Information Association (DIA EUROPE 2023), March 24th, 2023, Basel, Switzerland. Abstract ID:101264. Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment. 2023.
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Akpoviroro O, Castagne-Charlotin M, Joyce NP, Malikova MA. Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials. Ther Innov Regul Sci. 2023 Jul; 57(4):619-628. PMID: 36930415
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He Y, Shiu YT, Imrey PB, Radeva MK, Beck GJ, Gassman JJ, Northrup HM, Roy-Chaudhury P, Berceli SA, Cheung AK. Association of Shear Stress with Subsequent Lumen Remodeling in Hemodialysis Arteriovenous Fistulas. Clin J Am Soc Nephrol. 2023 Jan 01; 18(1):72-83. PMID: 36446600; PMCID: PMC10101625; DOI: 10.2215/CJN.04630422;
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Malikova M.A., Cole A., Trifirò G.; Racagni G., Van Liew D., Webster P., Brahmbhatt T. Frontiers in Drug Safety and Regulation. Establishing patient safety monitoring in the benefit-risk paradigm for off-label and emergency use of medications for COVID-19: A pharmacovigilance perspective. EPub. https://doi.org/10.3389/fdsfr.2022.1038235. 2022; 1-6. View Publication
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Malikova M.A. The Symposium on Advanced Wound Care (SAWC). October 13-16th, 2022, Las Vegas, Nevada, USA.Abstract Book. Building Quality by Design into Wound Care Trials with Combination Products. 2022; 83-84. View Publication
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Malikova M. and Kaliaev A. 21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities”. Risk-Based Quality and Safety Management in Clinical Trials with Combination Devices in Changing Global Regulatory Environment. Drug Safety. Drug Safety. 2022; (45):1267. View Publication
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Malikova M., Webster P., Brahmbhatt T. 21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23, September 2022 Verona, Italy. Establishing Patient Safety Monitoring in the Benefit-Risk Paradigm for Off-Label and Emergency Use of Medications for COVID-19: A Pharmacovigilance Perspective. Drug Safety. Drug Safety. 2022; (45):1199–1200. View Publication
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Palin K., V. Kugener V., Salas M., Malikova M., Price J., Webster P., Cole A., Ely D., Habibi S., Joshi P. 21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities”. Am2P: A New Accredited Academic Training Program in Pharmacovigilance and Pharmacoepidemiology Designed for US, Canadian and Caribbean Healthcare Professionals. Drug Safety. 2022; (45):1275–1276. View Publication
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Cole A, Webster P, Van Liew D, Salas M, Aimer O, Malikova MA. Safety surveillance and challenges in accelerated COVID-19 vaccine development. Ther Adv Drug Saf. 2022; 13:20420986221116452. PMID: 36072284; PMCID: PMC9444812; DOI: 10.1177/20420986221116452;
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Li Y, He Y, Falzon I, Fairbourn B, Tingey S, Imrey PB, Radeva MK, Beck GJ, Gassman JJ, Roy-Chaudhury P, Berceli SA, Cheung AK, Shiu YT. Dynamic Remodeling of Human Arteriovenous Fistula Wall Obtained From Magnetic Resonance Imaging During the First 6 Months After Creation. Kidney Int Rep. 2022 Aug; 7(8):1905-1909. PMID: 35967120; PMCID: PMC9366358; DOI: 10.1016/j.ekir.2022.05.016;
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Malikova M, Jara H, Slanetz PJ. Evaluation of non-palpable breast lesions by quantitative magnetic resonance imaging in correlation with histopathology and radiological findings. 2022. View Publication
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Malikova M.A. Optimizing Protocol Design for Special Populations: Evolving Challenges. Annual Europe Meeting, Drug Information Association (DIA EUROPE 2021), March 15-19, 2021, Basel, Switzerland. Abstract ID: 86126. 2021.
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Malikova M.A. Annual Europe Meeting, Drug Information Association (DIA EUROPE 2021), March 15-19, 2021, Basel, Switzerland. Safety and Risk Based Quality Management in Clinical Trials with Cell- Based Combination Products. 2021; Abstract ID: 92115.
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Malikova MA. Biologics Development: A Regulatory Overview. Chapter 15, Biosimilars. Barnette International Publishing Group. 2021. View Publication
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Malikova M.A. Impact of COVID-19 pandemic on conduct of clinical trials: lessons learned for risk and change management. International Journal of Clinical Trials. 2021; 8(1).
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Malikova M.A. The Impact of ICH GCP Guideline E6 R2 Revisions on Budgeting, Contracts, Resource Management in Globalization Environment. 32nd Annual Europe Meeting, Drug Information Association, June 29-July 2nd, 2020, Brussels, Belgium. Abstract ID: 86124. 2020.
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Kaliaev A., Anderson S. and Malikova M.A. Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment.32nd Annual Europe Meeting, Drug Information Association, June 29-July 2nd, 2020, Brussels, Belgium. Abstract ID: 86125. 2020.
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Malikova MA. Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance. Ther Adv Drug Saf. 2020; 11:2042098620909614. PMID: 32313617; PMCID: PMC7160767; DOI: 10.1177/2042098620909614;
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Kaliaev AO, Malikova MA. Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products in Changing Global Regulatory Environment. Ther Innov Regul Sci. 2020 07; 54(4):803-813. PMID: 32557305
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Malikova M.A. Risk-Based Quality and Safety Management in Clinical Trials with Combination Wound Care Products in Changing Global Regulatory Environment. SAWC. 2019. View Publication
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Kubiak RW, Zelnick LR, Hoofnagle AN, Alpers CE, Terry CM, Shiu YT, Cheung AK, de Boer IH, Robinson-Cohen C, Allon M, Dember LM, Feldman HI, Himmelfarb J, Huber TS, Roy-Chaudhury P, Vazquez MA, Kusek JW, Beck GJ, Imrey PB, Kestenbaum B. Mineral Metabolism Disturbances and Arteriovenous Fistula Maturation. Eur J Vasc Endovasc Surg. 2019 May; 57(5):719-728. PMID: 31000459; PMCID: PMC7259372; DOI: 10.1016/j.ejvs.2019.01.022;
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Kaliaev AO, Kharazov AF, Luchkin VM, Lisin SV, Malikova MA. The new type of hybrid open and endovascular techniques for limb preservation in patients with critical limb ischemia after multiple aortobifemoral bypass thrombosis and the absence of outflow arteries. Surgical Case Reports and Reviews. 2019; 3(1):1-9. View Publication
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Malikova MA. Biologics Development: A Regulatory Overview. Chapter 14, Special Topics: Gene Therapy, Cell – Based Therapeutics. Barnette International Publishing Group. 2019. View Publication
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Malikova M.A. The impact of ICH GCP E6 R2 guideline revisions on contracts, sites and vendor selection. Pharmaceutical Outsourcing. 2019; 20(4):20-26. View Publication
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Robbin ML, Greene T, Allon M, Dember LM, Imrey PB, Cheung AK, Himmelfarb J, Huber TS, Kaufman JS, Radeva MK, Roy-Chaudhury P, Shiu YT, Vazquez MA, Umphrey HR, Alexander L, Abts C, Beck GJ, Kusek JW, Feldman HI. Prediction of Arteriovenous Fistula Clinical Maturation from Postoperative Ultrasound Measurements: Findings from the Hemodialysis Fistula Maturation Study. J Am Soc Nephrol. 2018 11; 29(11):2735-2744. PMID: 30309898; PMCID: PMC6218859; DOI: 10.1681/ASN.2017111225;
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Allon M, Imrey PB, Cheung AK, Radeva M, Alpers CE, Beck GJ, Dember LM, Farber A, Greene T, Himmelfarb J, Huber TS, Kaufman JS, Kusek JW, Roy-Chaudhury P, Robbin ML, Vazquez MA, Feldman HI. Relationships Between Clinical Processes and Arteriovenous Fistula Cannulation and Maturation: A Multicenter Prospective Cohort Study. Am J Kidney Dis. 2018 05; 71(5):677-689.View Related Profiles. PMID: 29398178; PMCID: PMC5916528; DOI: 10.1053/j.ajkd.2017.10.027;
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Kaliaev AO, Bakhmetev AS, Bakhmeteva MS, Malikova MA. A rare clinical case of multivessel stenosis and lesions in patient with Takayasu's disease. World Journal of Surgery and Surgical Research. 2018; 1(1033):1-3. View Publication
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Malikova M.A. Practical aspects of developing relevant key performance and quality indicators for risk-based quality management in pharmacotherapy. Proceedings of 18th Annual Meeting of the International Society of Pharmacovigilance (ISoP). Drug Safety. 2018; 41(11):1234-1235. View Publication
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Malikova M.A. Considerations for third party vendor management in a risk-focused environment. Pharmaceutical Outsourcing. 2018; 19(4):1-8.
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Malikova M.A. Current methodologies utilized in the conduct of randomized clinical trials. Bawa R. and Audette G.F. (Editors) Current Issues in Medicine: Fundamentals and Basic Medical Sciences. 2018; Volume 1:Chapter 29:1-10.
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Alpers CE, Imrey PB, Hudkins KL, Wietecha TA, Radeva M, Allon M, Cheung AK, Dember LM, Roy-Chaudhury P, Shiu YT, Terry CM, Farber A, Beck GJ, Feldman HI, Kusek JW, Himmelfarb J. Histopathology of Veins Obtained at Hemodialysis Arteriovenous Fistula Creation Surgery. J Am Soc Nephrol. 2017 Oct; 28(10):3076-3088.View Related Profiles. PMID: 28724774; PMCID: PMC5619951; DOI: 10.1681/ASN.2016050598;
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Cheung AK, Imrey PB, Alpers CE, Robbin ML, Radeva M, Larive B, Shiu YT, Allon M, Dember LM, Greene T, Himmelfarb J, Roy-Chaudhury P, Terry CM, Vazquez MA, Kusek JW, Feldman HI. Intimal Hyperplasia, Stenosis, and Arteriovenous Fistula Maturation Failure in the Hemodialysis Fistula Maturation Study. J Am Soc Nephrol. 2017 Oct; 28(10):3005-3013. PMID: 28710091; PMCID: PMC5619966; DOI: 10.1681/ASN.2016121355;
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Malikova MA, Tkacz JN, Slanetz PJ, Guo CY, Aakil A, Jara H. Evaluation of T1/T2 ratios in a pilot study as a potential biomarker of biopsy: proven benign and malignant breast lesions in correlation with histopathological disease stage. Future Sci OA. 2017 Aug; 3(3):FSO197.View Related Profiles. PMID: 28883997; PMCID: PMC5583698; DOI: 10.4155/fsoa-2016-0063;
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Malikova M.A, Tkacz J.N, Slanetz P. J., Aakil A., Guo Chao-Yu, and Jara H. Evaluation of T1/T2 ratios in a pilot study as a potential biomarker of biopsy - proven benign and malignant breast lesions in correlation with histopathological disease stage. 2017.
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Malikova M. A. Building quality assurance (QA) and risk-based quality management (RBQM) systems into clinical research operations. An academic site perspective. Journal of Clinical Trials and Regulatory Affairs. 2017; 1(1):1-8.
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Bakhmetev AS, Kaliaev AO, Sukhoruchkin AA, Malikova MA. The effect of mobile phone electromagnetic radiation on brain vessels. Surgical Cases Reports and Reviews. 2017; 1(1):1-3. View Publication
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Bakhmetev AS, Kaliaev AO, Zotkin VV, Sukhoruchkin AA, Loiko VS, Malikova MA. Transverse flatfoot is a potential risk factor for development of varicose veins in the lower extremities of middle-aged women. Clinics in Surgery. 2017; 2(1552):1-4.
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Dember LM, Imrey PB, Duess MA, Hamburg NM, Larive B, Radeva M, Himmelfarb J, Kraiss LW, Kusek JW, Roy-Chaudhury P, Terry CM, Vazquez MA, Vongpatanasin W, Beck GJ, Vita JA. Vascular Function at Baseline in the Hemodialysis Fistula Maturation Study. J Am Heart Assoc. 2016 Jul 22; 5(7).View Related Profiles. PMID: 27451463; PMCID: PMC5015367; DOI: 10.1161/JAHA.116.003227;
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Malikova MA. Optimization of protocol design: a path to efficient, lower cost clinical trial execution. Future Sci OA. 2016 Mar; 2(1):FSO89. PMID: 28031939; PMCID: PMC5137936; DOI: 10.4155/fso.15.89;
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Krafcik BM & Malikova MA. Implementation of quality and risk management strategies in wound care trials. Int J Clin Trials. 2016; 3(3):89-97. View Publication
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Farber A, Imrey PB, Huber TS, Kaufman JM, Kraiss LW, Larive B, Li L, Feldman HI. Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study. J Vasc Surg. 2016 Jan; 63(1):163-70.e6.View Related Profiles. PMID: 26718822; PMCID: PMC4698902; DOI: 10.1016/j.jvs.2015.07.086;
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Robbin ML, Greene T, Cheung AK, Allon M, Berceli SA, Kaufman JS, Allen M, Imrey PB, Radeva MK, Shiu YT, Umphrey HR, Young CJ. Arteriovenous Fistula Development in the First 6 Weeks after Creation. Radiology. 2016 May; 279(2):620-9. PMID: 26694050; PMCID: PMC4851120; DOI: 10.1148/radiol.2015150385;
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Malikova M.A. A Systematic Approach to Study Start-Up. Drug Information Association (DIA), 51st Annual Meeting, June 14-18th, 2015, Washington, DC, USA. 2015. View Publication
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Krafcik B. M., Malikova M.A. The Symposium on Advanced Wound Care (SAWC). April 29-May 3rd, 2015, San Antonio, TX, USA. Implementation of Quality and Risk Management Strategies in Wound Care Trials. 2015; Abstract ID: CS-14017 . View Publication
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Malikova M., Tkacz J.N., Slanetz P.J., Aakil A., Guo C.-Y., Jara H. Evaluation of T1/T2 ratios in a pilot study as a potential biomarker of biopsy - proven benign and malignant breast lesions in correlation with histopathological disease stage. Insights into Imaging. 2015.
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Krafcik B. M., Malikova M.A. Implementation of quality by design (QbD) and quality risk management (QRM) strategies in pharmacovigilance for wound care trials. Proceedings of 15th Annual Meeting of the International Society of Pharmacovigilance (ISoP). Drug Safety. 2015; 38(10):1043-1044.
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Malikova M.A. Practical aspects of developing relevant key performance and quality indicators (KP-QIs) for risk-based quality management (RBQM) in pharmacotherapy. Proceedings of 15th Annual Meeting of the International Society of Pharmacovigilance (ISoP). Drug Safety. 2015; 38(10):1043-1044.
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Malikova MA, Shifflett L, Farber A. Implementation of strategic management tools improves wound care clinical trial outcomes. Clin. Invest. (Lond.). 2015; 5(7):653-664. View Publication
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Eslami MH, Doros G, Goodney PP, Elderup-Jorgenson J, Cronenwett JL, Malikova M, Farber A. Using vascular quality initiative as a platform for organizing multicenter, prospective, randomized clinical trials: OVERPAR trial. Ann Vasc Surg. 2015 Feb; 29(2):278-85.View Related Profiles. PMID: 25311746; PMCID: PMC4314323; DOI: 10.1016/j.avsg.2014.08.007;
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Malikova M. A. 50th Annual Meeting, San Diego, CA, USA. Building Quality by Design (QbD) and Quality Risk Management (QRM) Systems into Clinical Site Operations. 2014; Abstract ID: 55571.
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Malikova M.A., Tkacz J.N., Aakil A., Slanetz P.J., Guo C.-Y., Jara H. Evaluation of T1/T2 ratios obtained by quantitative MRI in a pilot study as a potential biomarker to monitor response to treatment of biopsy-proven malignant breast lesions and assessment tool for involvement of contralateral breast. 2014.
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Dember LM, Imrey PB, Beck GJ, Cheung AK, Himmelfarb J, Huber TS, Kusek JW, Roy-Chaudhury P, Vazquez MA, Alpers CE, Robbin ML, Vita JA, Greene T, Gassman JJ, Feldman HI. Objectives and design of the hemodialysis fistula maturation study. Am J Kidney Dis. 2014 Jan; 63(1):104-12.View Related Profiles. PMID: 23992885; PMCID: PMC4134933; DOI: 10.1053/j.ajkd.2013.06.024;
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Farber A, Belenky A, Malikova M, Brenner O, Brandeis Z, Migdal M, Orron D, Kim D. The evaluation of a novel technique to treat saphenous vein incompetence: preclinical animal study to examine safety and efficacy of a new vein occlusion device. Phlebology. 2014 Feb; 29(1):16-24.View Related Profiles. PMID: 23202139; DOI: 10.1258/phleb.2012.012003;
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Malikova M.A., Tkacz J.N., Slanetz P.J., Aakil A., Guo C. Y., Jara H. . Evaluation of T1/T2 ratios in a pilot study as a potential biomarker of biopsy: proven benign and malignant breast lesions in correlation with histopathological disease stage. 2013.
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Malikova M.A., Shifflett L., Farber A. The 3rd Annual Society of Advanced Wound Care (SAWC) Symposium. October 13 – 15, 2011. Las Vegas, NV, USA. Implementation of Strategic Management Tools Improves Wound Care Clinical Trial Outcomes. 2011. View Publication
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Malikova MA, Doros G, Joglar F, Rybin D, Petros JG, Farber A. A third-year surgery clerkship with extensive exposure to vascular surgery improves knowledge about vascular disease and the role of vascular surgeons in its management. Vasc Endovascular Surg. 2010 Jul; 44(5):361-7.View Related Profiles. PMID: 20484079; DOI: 10.1177/1538574410362111;
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Malikova M.A., Tkacz J.N., Slanetz P.J., Aakil A., Jara H.J. Quantitative MRI technique for mapping the T1/T2 ratios of benign and malignant breast lesions. Insights into Imaging. 2010. View Publication
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Malikova M. A., Tkacz J. N., Yaakil A., Slanetz P., and Jara H. . Quantitative MRI Technique for Mapping the T1/T2 Ratios of Benign and Malignant Breast Lesions. Scientific Meeting Proceedings of 17th Annual International Society of Magnetic Resonance in Medicine (ISMRM). 2009.
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Farber A., Belenky A., Malikova M., Karmeli R., Brenner O., Migdal M., Kim. D. Journal of Vascular Interventional Radiology. Preclinical animal study to evaluate safety and efficacy of a novel V-Block device to treat saphenous vein incompetence. 2009; (12):S72-73. View Publication
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Malikova M, Shi J, Kandror KV. V-type ATPase is involved in biogenesis of GLUT4 vesicles. Am J Physiol Endocrinol Metab. 2004 Sep; 287(3):E547-52.View Related Profiles. PMID: 15166000
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Semin BV, Malikova MA, Stepanova AS, Ul'in IuV. [Homologous and heterologous type 2 casein kinases have the same effect on the affinity for RNA of the Gag structural glycoprotein of gypsy (MDG4)]. Mol Biol (Mosk). 2002 Jan-Feb; 36(1):40-2. PMID: 11862711
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Semin BV, Popenko VI, Malikova MA, Turapov OA, Stepanov AS, Ilyin Y. The polyprotein gag of retroelement gypsy can form multimeric complexes when expressed in bacterial system. Dokl Biochem Biophys. 2001 Sep-Oct; 380:322-4. PMID: 11727555
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Malikova MA, Syomin BV, Stepanov AS. Phosphorylation of the protein encoded by the first open reading frame of the MDG4 transposable element (gypsy) by homologous and heterologous casein kinases type 2. Biochemistry (Mosc). 2001 Feb; 66(2):205-10. PMID: 11255129
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Malikova M.A. 35th Annual Europe Meeting, Drug Information Association (DIA EUROPE 2023).March 24th, 2023, Basel, Switzerland. Abstract ID:101264. Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment.
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Malikova M.A. Innovative Clinical Trial Design: Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Changing Global Regulatory Environment. Session ID: 22, Innovative Cli.
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Malikova M.A. Abstracts of ICPE 2022, the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), Copenhagen, Denmark, 26–28 August, 2022. Pharmacoepidemiology and benefit/risk management strategies in clinical trials with cell-based combination products. Pharmacoepidemiology and Drug Safety. (S2)(31):1053-8569. View Publication
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Malikova M.A. Signal detection and risks communication in pharmacovigilance for cardiovascular clinical trials. Proceedings of 18th Annual Meeting of the International Society of Pharmacovigilance (ISoP). Drug Safety. 41(11):1253-1254.
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Schneider A.C., Cilley K.N., Malikova M.A. Impact of Social Determinants of Health on Safety of Patients in Device Clinical Trials Conducted at a Safety-Net Hospital. 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics” 1–5 October 2024 Montreal, Canada. Drug Saf (2024). View Publication
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Joyce N.P., Roddy C. M., Malikova M.A. Safety and Risk-Management in Clinical Trials with Tissue Regenerative Products. 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics” 1–5 October 2024 Montreal, Canada. Drug Saf (2024). View Publication
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Cilley K.N., Schneider A.C., Malikova M.A. Impact of Social Determinants of Health on Patient Safety in Wound Care Clinical Trials with Combination Products. The Symposium on Advanced Wound Care (SAWC). October 2-5th, 2024, Las Vegas, Nevada, USA. Abstract ID#1846127. E-Poster ID#CR-011,. View Publication
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Kugener V., Palin K., Malikova M. October 1-5th, 2024. Montreal, Canada. Drug Saf (2024). The American Program in Pharmacovigilance (Am2P): A New Accredited Training Program in Pharmacovigilance and Pharmacoepidemiology. View Publication
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Drinkwater C., Salas M., Januzzi J., Challa A., Hammad T., Armen Ghazarian A., Gossell-Williams M., Merchant L., Rebecca Chandler R., Noss R.,
Malikova M., Junaid T. . A Systematic Literature Review of the Long-Term Adverse Events Associated with COVID-19 Vaccines. Drug Saf (2024)
. View Publication