NikolayNikolovMD

PubMed

• American College of Rheumatology (ACR) and Food and Drug Administration (FDA) Summit: Summary of the Meeting May 17-18, 2022.
  Michael H Weisman, , Jonathan Kay, Nikolay P Nikolov> ;Arthritis & Rheumatology. 2024 Apr 15
• 1 citations
  Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization.
  Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Ozlem Belen, Van Tran, Rebecca Chiu, Karen Higgins, Jianmeng Chen, Lei He, Suresh Doddapaneni, Shiew-Mei Huan...> ;Clinical Pharmacology and Therapeutics. 2024 Apr 1
• 1 citations
  Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.
  Laura E Schanberg, Lily Yeruk Mulugeta, Bolanle Akinlade, Hermine I Brunner, Jianmeng Chen, Robert A Colbert, Vincent Delgaizo, Marc R Gastonguay, Rachel Glaser, Lisa ...> ;Arthritis & Rheumatology. 2023 Oct 1
• 8 citations
  FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit.
  Jason S Kim, Silvana Borges, Daniel J Clauw, Philip G Conaghan, David T Felson, Thomas R Fleming, Rachel Glaser, Elizabeth Hart, Marc Hochberg, Yura Kim, Virginia B Kr...> ;Seminars in Arthritis and Rheumatism. 2022 Oct 1
• 10 citations
  Clinical pharmacology considerations for the approval of belimumab for the treatment of adult patients with active lupus nephritis: A regulatory perspective.
  Tao Liu, Rosemarie Neuner, Aliza Thompson, Ginto Pottackal, David Petullo, Jiang Liu, Nikolay Nikolov, Chandrahas Sahajwalla, Suresh Doddapaneni, Jianmeng Chen> ;Lupus. 2022 Apr 1
• 8 citations
  Response Similarity Assessment Between Polyarticular Juvenile Idiopathic Arthritis and Adult Rheumatoid Arthritis for Biologics.
  Renu Singh, Vijay Ivaturi, Justin Penzenstadler, Tao Liu, Jianmeng Chen, Anshu Marathe, Ping Ji, Rachel Glaser, Nikolay P Nikolov, Chandrahas G. Sahajwalla> ;Clinical Pharmacology and Therapeutics. 2021 Jul 1
• 17 citations
  Concept Endpoints Informing Design Considerations for Confirmatory Clinical Trials in Osteoarthritis.
  Yura Kim, Gregory Levin, Nikolay P Nikolov, Robert Abugov, Rebecca Rothwell> ;Arthritis Care & Research. 2020 Dec 20
• 5 citations
  Immunomodulatory Therapeutic Proteins in COVID-19: Current Clinical Development and Clinical Pharmacology Considerations.
  Ping Ji, Jianmeng Chen, Amit Golding, Nikolay P. Nikolov, Bhawana Saluja, Yunzhao R. Ren, Chandrahas G. Sahajwalla> ;Journal of Clinical Pharmacology. 2020 Oct 1
• 11 citations
  A Comprehensive Updated Review on SARS-CoV-2 and COVID-19.
  Yunzhao R. Ren, Amit Golding, Alfred Sorbello, Ping Ji, Jianmeng Chen, Bhawana Saluja, Kimberly Witzmann, Vikram Arya, Kellie S. Reynolds, Su Young Choi, Nikolay P. Ni...> ;Journal of Clinical Pharmacology. 2020 Aug 1
• 2 citations
  Noninferiority Trials to Evaluate Drug Effects in Rheumatoid Arthritis.
  Rebecca Rothwell, Nikolay P. Nikolov, Janet W. Maynard, Gregory Levin> ;Arthritis & Rheumatology. 2020 Aug 1
• 1 citations
  Underscoring the Importance of Allopurinol in Treating Gout: Results of a Food and Drug Administration-Mandated Safety Trial
  Nikolay P. Nikolov, Sally Seymour, Rosemarie Neuner, Ya‐Hui Hsueh, Eugenio Andraca-Carrera, Kusum Mistry> ;Arthritis & Rheumatology. 2020 Jun 1
• 2 citations
  A Novel Pharmacokinetic Bridging Strategy to Support a Change in the Route of Administration for Biologics
  Ping Ji, Nikolay P. Nikolov, Sally Seymour, Rachel Glaser, Yupeng Ren, Liang Li, Anshu Marathe, Yunzhao Ren, Jianmeng Chen, Lei He, Dipak Pisal, Shalini Wickramaratne ...> ;Journal of Pharmaceutical Sciences. 2019 Jul 1
• 34 citations
  Late responses to adenoviral-mediated transfer of the aquaporin-1 gene for radiation-induced salivary hypofunction
  Ilias Alevizos, Changyu Zheng, Ana P. Cotrim, Shuying Liu, Linda McCullagh, M E Billings, CM Goldsmith, Mayank Tandon, Eva J. Helmerhorst, Marcelo A. Catalán, S J Dani...> ;Gene Therapy. 2017 Mar 1
• 9 citations
  Immune reactivity after adenoviral-mediated aquaporin-1 cDNA transfer to human parotid glands.
  Ilias Alevizos, Changyu Zheng, Ana P. Cotrim, Corinne M. Goldsmith, Linda McCullagh, Theodore Berkowitz, Susan L. Strobl, Anatoli Malyguine, William C. Kopp, John A. C...> ;Oral Diseases. 2017 Feb 8
• 13 citations
  An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology.
  Nikolay P. Nikolov, Marjorie A. Shapiro> ;Nature Reviews. Rheumatology. 2017 Feb 1
• 22 citations
  Predominant Glandular Cholinergic Dysautonomia in Patients With Primary Sjögren's Syndrome.
  Richard Imrich, Ilias Alevizos, Lolita Bebris, David S. Goldstein, Courtney Holmes, Gabor G. Illei, Nikolay P. Nikolov> ;Arthritis & Rheumatology. 2015 May 1
• 127 citations
  Early responses to adenoviral-mediated transfer of the aquaporin-1 cDNA for radiation-induced salivary hypofunction.
  Bruce J. Baum, Ilias Alevizos, Changyu Zheng, Ana P. Cotrim, Shuying Liu, Linda McCullagh, Corinne M. Goldsmith, Peter D. Burbelo, Deborah Citrin, James B. Mitchell, L...> ;Proceedings of the National Academy of Sciences of the United States of America. 2012 Nov 20
• A novel hybrid adenoretroviral vector with more extensive E3 deletion extends transgene expression in submandibular glands.
  Zheng, C., Cotrim, A. P., Nikolov, N., Mineshiba, F., Swaim, W., Baum, B. J.> ;Hum Gene Ther Methods. 2012 Jun 29
• 6 citations
  A Novel Hybrid Adenoretroviral Vector with More Extensive E3 Deletion Extends Transgene Expression in Submandibular Glands
  Changyu Zheng, Ana P. Cotrim, Nikolay P. Nikolov, Fumi Mineshiba, William D. Swaim, Bruce J. Baum> ;Human Gene Therapy Methods. 2012 Jun 11
• 4 citations
  Adrenomedullary response to glucagon in patients with primary Sjögren's syndrome.
  Richard Imrich, Nikolay P. Nikolov, Lolita Bebris, Ilias Alevizos, David S. Goldstein, Courtney Holmes, Gabor G. Illei> ;Cellular and Molecular Neurobiology. 2012 Feb 18
• 14 citations
  Development of IgA nephropathy-like glomerulonephritis associated with Wiskott-Aldrich syndrome protein deficiency
  Masaki Shimizu, Nikolay P. Nikolov, Kazuyuki Ueno, Kazuhide Ohta, Richard M. Siegel, Akihiro Yachie, Fabio Candotti> ;Clinical Immunology. 2012 Feb 1
• 37 citations
  Systemic autoimmunity and defective Fas ligand secretion in the absence of the Wiskott-Aldrich syndrome protein.
  Nikolay P. Nikolov, Masaki Shimizu, Sophia Y. Cleland, Daniel Bailey, Joseph Aoki, Ted S. Strom, Pamela L. Schwartzberg, Fabio Candotti, Richard M. Siegel> ;Blood. 2010 Aug 5
• 22 citations
  Transient detection of E1-containing adenovirus in saliva after the delivery of a first-generation adenoviral vector to human parotid gland.
  Changyu Zheng, Nikolay P. Nikolov, Ilias Alevizos, Ana P. Cotrim, Shuying Liu, Linda McCullagh, John A. Chiorini, Gabor G. Illei, Bruce J. Baum> ;The Journal of Gene Medicine. 2010 Jan 1
• Development of a gene transfer-based treatment for radiation-induced salivary hypofunction.
  Baum, B. J., Zheng, C., Alevizos, I., Cotrim, A. P., Liu, S., McCullagh, L., Goldsmith, C. M., McDermott, N., Chiorini, J. A., Nikolov, N. P., Illei, G. G.> ;Oral Oncol. 2009 Nov 07
• 33 citations
  Sensitive and robust luminescent profiling of anti-La and other autoantibodies in Sjogren's syndrome.
  Peter D. Burbelo, Hannah P. Leahy, Alexandra T. Issa, Sandra Groot, James N. Baraniuk, Nikolay P. Nikolov, Gabor G. Illei, Michael J. Iadarola> ;Autoimmunity. 2009 Sep 9
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