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Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper.
Samineni D, Venkatakrishnan K, Othman AA, Pithavala YK, Poondru S, Patel C, Vaddady P, Ankrom W, Ramanujan S, Budha N, Wu M, Haddish-Berhane N, Fritsch H, Hussain A, Kanodia J, Li M, Li M, Melhem M, Parikh A, Upreti VV, Gupta N. Samineni D, et al. Among authors: upreti vv. Clin Pharmacol Ther. 2024 May 16. doi: 10.1002/cpt.3298. Online ahead of print. Clin Pharmacol Ther. 2024. PMID: 38752712 Review.
An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Gokemeijer J, Balasubramanian N, Ogasawara K, Grudzinska-Goebel J, Upreti VV, Mody H, Kasar S, Vepachedu VR, Xu W, Gupta S, Tarcsa E, Dodge R, Herr K, Yang TY, Tourdot S, Jawa V. Gokemeijer J, et al. Among authors: upreti vv. Clin Pharmacol Ther. 2024 Feb;115(2):188-200. doi: 10.1002/cpt.3111. Epub 2023 Dec 17. Clin Pharmacol Ther. 2024. PMID: 37983584 Review.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. Among authors: upreti vv. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.
Mody H, Ogasawara K, Zhu X, Miles D, Shastri PN, Gokemeijer J, Liao MZ, Kasichayanula S, Yang TY, Chemuturi N, Gupta S, Jawa V, Upreti VV. Mody H, et al. Among authors: upreti vv. Clin Pharmacol Ther. 2023 Sep;114(3):530-557. doi: 10.1002/cpt.2986. Epub 2023 Jul 26. Clin Pharmacol Ther. 2023. PMID: 37393588 Review.
50 results