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Page 1
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: chemuturi n. 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: chemuturi n. 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.
Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper.
Kraynov E, Kamath AV, Walles M, Tarcsa E, Deslandes A, Iyer RA, Datta-Mannan A, Sriraman P, Bairlein M, Yang JJ, Barfield M, Xiao G, Escandon E, Wang W, Rock DA, Chemuturi NV, Moore DJ. Kraynov E, et al. Among authors: chemuturi nv. Drug Metab Dispos. 2016 May;44(5):617-23. doi: 10.1124/dmd.115.068049. Epub 2015 Dec 15. Drug Metab Dispos. 2016. PMID: 26669328 Review.
International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs.
Pruimboom-Brees IM, Gupta S, Chemuturi N, Booler HS, Nimz E, Ferrell Ramos M, Caruso A, Maass KF, Bantseev V, Huang Q, Choules MP, Nussbaum JC, Kanodia J, Thompson C, Durairaj C. Pruimboom-Brees IM, et al. Among authors: chemuturi n. Clin Transl Sci. 2023 May;16(5):723-741. doi: 10.1111/cts.13480. Epub 2023 Feb 2. Clin Transl Sci. 2023. PMID: 36651217 Free PMC article.
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Leach MW, Clarke DO, Dudal S, Han C, Li C, Yang Z, Brennan FR, Bailey WJ, Chen Y, Deslandes A, Loberg LI, Mayawala K, Rogge MC, Todd M, Chemuturi NV. Leach MW, et al. Among authors: chemuturi nv. Clin Pharmacol Ther. 2021 Jun;109(6):1395-1415. doi: 10.1002/cpt.2009. Epub 2020 Nov 3. Clin Pharmacol Ther. 2021. PMID: 32757299
14 results