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Industry Perspective on First-in-Human and Clinical Pharmacology Strategies to Support Clinical Development of T-Cell Engaging Bispecific Antibodies for Cancer Therapy.
Nagaraja Shastri P, Shah N, Lechmann M, Mody H, Retter MW, Zhu M, Li T, Wang J, Shaik N, Zheng X, Ovacik M, Hua F, Jawa V, Boetsch C, Cao Y, Burke J, Datta K, Gadkar K, Upreti V, Betts A. Nagaraja Shastri P, et al. Among authors: datta k. Clin Pharmacol Ther. 2025 Jan;117(1):34-55. doi: 10.1002/cpt.3439. Epub 2024 Sep 19. Clin Pharmacol Ther. 2025. PMID: 39295563 Review.
Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC).
Matsumoto M, Polli JR, Swaminathan SK, Datta K, Kampershroer C, Fortin MC, Salian-Mehta S, Dave R, Yang Z, Arora P, Hiura M, Suzuki M, Brennan FR, Sathish J. Matsumoto M, et al. Among authors: datta k. Clin Pharmacol Ther. 2024 Sep;116(3):546-562. doi: 10.1002/cpt.3316. Epub 2024 Jun 7. Clin Pharmacol Ther. 2024. PMID: 38847597 Review.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Chien HT, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Schutte K, Sewell F, Trouba K, Ulrich P, Weir L, van Meer P. Chien HT, et al. Among authors: datta k. Regul Toxicol Pharmacol. 2023 Feb;138:105329. doi: 10.1016/j.yrtph.2022.105329. Epub 2022 Dec 30. Regul Toxicol Pharmacol. 2023. PMID: 36592682 Free article.
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Prior H, Andrews L, Cauvin A, Chien H, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Reid K, Schutte K, Sewell F, Trouba K, Ulrich P, van Aerts L, van Meer P, Weir L. Prior H, et al. Among authors: datta k. Regul Toxicol Pharmacol. 2023 Feb;138:105339. doi: 10.1016/j.yrtph.2023.105339. Epub 2023 Jan 14. Regul Toxicol Pharmacol. 2023. PMID: 36649820 Free article. Review.
Opportunities and challenges for use of minipigs in nonclinical pharmaceutical development: Results of a follow-up IQ DruSafe survey.
Clarke DO, Datta K, French K, Leach MW, Olaharski D, Mohr S, Strein D, Bussiere J, Feyen B, Gauthier BE, Graziano M, Harding J, Hershman K, Jacob B, Ji S, Lange R, Salian-Mehta S, Sayers B, Thomas N, Flandre T. Clarke DO, et al. Among authors: datta k. Regul Toxicol Pharmacol. 2024 Dec;154:105729. doi: 10.1016/j.yrtph.2024.105729. Epub 2024 Oct 30. Regul Toxicol Pharmacol. 2024. PMID: 39481797 Free article.
Sleep duration at night affects daytime wake EEG spectra.
Anurag A, Datta K, Bhutambare A, Vl M, Narawade Y, Kumar S. Anurag A, et al. Among authors: datta k. Med J Armed Forces India. 2024 Dec;80(Suppl 1):S144-S152. doi: 10.1016/j.mjafi.2023.01.007. Epub 2023 Apr 3. Med J Armed Forces India. 2024. PMID: 39734855
Searches for Pair-Produced Multijet Resonances Using Data Scouting in Proton-Proton Collisions at sqrt[s]=13  TeV.
Hayrapetyan A, Tumasyan A, Adam W, Andrejkovic JW, Bergauer T, Chatterjee S, Damanakis K, Dragicevic M, Hussain PS, Jeitler M, Krammer N, Li A, Liko D, Mikulec I, Schieck J, Schöfbeck R, Schwarz D, Sonawane M, Templ S, Waltenberger W, Wulz CE, Darwish MR, Janssen T, Van Mechelen P, Breugelmans N, D'Hondt J, Dansana S, De Moor A, Delcourt M, Heyen F, Lowette S, Makarenko I, Müller D, Tavernier S, Tytgat M, Van Onsem GP, Van Putte S, Vannerom D, Clerbaux B, Das AK, De Lentdecker G, Evard H, Favart L, Gianneios P, Hohov D, Jaramillo J, Khalilzadeh A, Khan FA, Lee K, Mahdavikhorrami M, Malara A, Paredes S, Thomas L, Vanden Bemden M, Vander Velde C, Vanlaer P, De Coen M, Dobur D, Gokbulut G, Hong Y, Knolle J, Lambrecht L, Marckx D, Mestdach G, Mota Amarilo K, Rendón C, Samalan A, Skovpen K, Van Den Bossche N, van der Linden J, Wezenbeek L, Benecke A, Bethani A, Bruno G, Caputo C, De Favereau De Jeneret J, Delaere C, Donertas IS, Giammanco A, Guzel AO, Jain S, Lemaitre V, Lidrych J, Mastrapasqua P, Tran TT, Wertz S, Alves GA, Coelho E, Hensel C, Menezes De Oliveira T, Moraes A, Rebello Teles P, Soeiro M, Vilela Pereira A, Aldá Júnior WL, Alves Gallo Pereira M, Barroso Ferreira Filho M, … See abstract for full author list ➔ Hayrapetyan A, et al. Among authors: datta k. Phys Rev Lett. 2024 Nov 15;133(20):201803. doi: 10.1103/PhysRevLett.133.201803. Phys Rev Lett. 2024. PMID: 39626745
743 results