Nikolay P. Nikolov

Center for Drug Evaluation and Research — United States

Medicine · Health Sciences

22h-index1.7kcitations56works4.02yr avg
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Research Topics

Salivary Gland Disorders and Functions(10), Rheumatoid Arthritis Research and Therapies(8), Monoclonal and Polyclonal Antibodies Research(6), Systemic Lupus Erythematosus Research(5), Autoimmune and Inflammatory Disorders Research(4)

Publications56 total

Recommendations for the use of CLASI as an outcome measure in cutaneous lupus erythematosus clinical trials
Nature Reviews Rheumatology·2026
Application of Bayesian statistics to support approval of intravenous belimumab in children with systemic lupus erythematosus in the United States
Lupus·2025· 4 cited
Model‐Informed Drug Development‐Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with Active Psoriatic Arthritis, Active Ankylosing Spondylitis, and Active Non‐Radiographic Axial Spondyloarthritis
Clinical Pharmacology & Therapeutics·2024· 3 citedOpen Access
Management of health during pandemic circumstances – economic and medico-social consequences
Bulgarian Portal for Open Science·2024Open Access
American College of Rheumatology and Food and Drug Administration Summit: Summary of the Meeting, May 17–18, 2022
Arthritis & Rheumatology·2024· 3 cited
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of <scp>COVID</scp>‐19 Under the Emergency Use Authorization
Clinical Pharmacology & Therapeutics·2024· 14 citedOpen Access
Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design
Arthritis & Rheumatology·2023· 6 citedOpen Access
FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit
Seminars in Arthritis and Rheumatism·2022· 29 citedOpen Access
Clinical pharmacology considerations for the approval of belimumab for the treatment of adult patients with active lupus nephritis: A regulatory perspective
Lupus·2022· 23 cited
Inhibition of miR-99a-5p prevents allergen-driven airway exacerbations without compromising type-2 memory responses in the intestine following helminth infection
Mucosal Immunology·2021· 8 citedOpen Access
Response Similarity Assessment Between Polyarticular Juvenile Idiopathic Arthritis and Adult Rheumatoid Arthritis for Biologics
Clinical Pharmacology & Therapeutics·2021· 13 cited
Concept End Points Informing Design Considerations for Confirmatory Clinical Trials in Osteoarthritis
Arthritis Care & Research·2020· 31 cited
Immunomodulatory Therapeutic Proteins in COVID‐19: Current Clinical Development and Clinical Pharmacology Considerations
The Journal of Clinical Pharmacology·2020· 9 citedOpen Access
A Comprehensive Updated Review on SARS‐CoV‐2 and COVID‐19
The Journal of Clinical Pharmacology·2020· 20 citedOpen Access
Underscoring the Importance of Allopurinol in Treating Gout: Results of a Food and Drug Administration–Mandated Safety Trial
Arthritis & Rheumatology·2020· 2 cited
Noninferiority Trials to Evaluate Drug Effects in Rheumatoid Arthritis
Arthritis & Rheumatology·2020· 5 cited
A Novel Pharmacokinetic Bridging Strategy to Support a Change in the Route of Administration for Biologics
Journal of Pharmaceutical Sciences·2019· 8 cited
Epithelial-Cell-Derived Phospholipase A 2 Group 1B Is an Endogenous Anthelmintic
Cell Host & Microbe·2017· 46 citedOpen Access
An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology
Nature Reviews Rheumatology·2017· 18 cited
Late responses to adenoviral-mediated transfer of the aquaporin-1 gene for radiation-induced salivary hypofunction
Gene Therapy·2016· 68 citedOpen Access
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Frequent Co-authors

Gabor G. Illei(12), Ilias Alevizos(7), Chandrahas Sahajwalla(7), Jianmeng Chen(7), Bruce J. Baum(6), Ana P. Cotrim(6), Richard M. Siegel(6), Linda McCullagh(5), Mark S. Wilson(5), Changyu Zheng(5), Shuying Liu(4), Corinne M. Goldsmith(4), John A. Chiorini(4), Stephanie M. Coomes(4), Yashaswini Kannan(4), Victoria S. Pelly(4), Lewis J. Entwistle(4), Stephanie Czieso(4), Rebecca Rothwell(4), R. Gläser(4)