Works matching AU Upreti, Vijay V

Results: 39
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    An Innovative Approach to Optimize First‐In‐Human Minimal Anticipated Biological Effect Level Based Starting Dose in Oncology Trials for Bispecific T‐Cell Engagers: Experience from A Solid Tumor Bispecific T‐Cell Engager.

    Published in:
    Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 225, doi. 10.1002/cpt.3431
    By:
    • Zhou, Di;
    • Kischel, Roman;
    • Stienen, Sabine;
    • Townsley, Danielle;
    • Sternjak, Alexander;
    • Lutteropp, Michael;
    • Bailis, Julie;
    • Friedrich, Matthias;
    • Rattel, Benno;
    • Mehta, Khamir;
    • Upreti, Vijay V.
    Publication type:
    Article
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    Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper.

    Published in:
    Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 3, p. 531, doi. 10.1002/cpt.3298
    By:
    • Samineni, Divya;
    • Venkatakrishnan, Karthik;
    • Othman, Ahmed A.;
    • Pithavala, Yazdi K.;
    • Poondru, Srinivasu;
    • Patel, Chirag;
    • Vaddady, Pavan;
    • Ankrom, Wendy;
    • Ramanujan, Saroja;
    • Budha, Nageshwar;
    • Wu, Michael;
    • Haddish‐Berhane, Nahor;
    • Fritsch, Holger;
    • Hussain, Azher;
    • Kanodia, Jitendra;
    • Li, Meng;
    • Li, Mengyao;
    • Melhem, Murad;
    • Parikh, Apurvasena;
    • Upreti, Vijay V.
    Publication type:
    Article
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    Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program.

    Published in:
    Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 2, p. 282, doi. 10.1002/cpt.3245
    By:
    • Galluppi, Gerald R.;
    • Ahamadi, Malidi;
    • Bhattacharya, Souvik;
    • Budha, Nageshwar;
    • Gheyas, Ferdous;
    • Li, Chi‐Chung;
    • Chen, Yuan;
    • Dosne, Anne‐Gaëlle;
    • Kristensen, Niels Rode;
    • Magee, Mindy;
    • Samtani, Mahesh N.;
    • Sinha, Vikram;
    • Taskar, Kunal;
    • Upreti, Vijay V.;
    • Yang, Jianning;
    • Cook, Jack
    Publication type:
    Article
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    An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR‐T and TCR‐T Cellular Therapies Development.

    Published in:
    Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 2, p. 188, doi. 10.1002/cpt.3111
    By:
    • Gokemeijer, Jochem;
    • Balasubramanian, Nanda;
    • Ogasawara, Ken;
    • Grudzinska‐Goebel, Joanna;
    • Upreti, Vijay V.;
    • Mody, Hardik;
    • Kasar, Siddha;
    • Vepachedu, Venkata R.;
    • Xu, Weifeng;
    • Gupta, Swati;
    • Tarcsa, Edit;
    • Dodge, Robert;
    • Herr, Kate;
    • Yang, Tong‐Yuan;
    • Tourdot, Sophie;
    • Jawa, Vibha
    Publication type:
    Article
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    Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR‐T and TCR‐T Cell Therapies: An Industry Perspective.

    Published in:
    Clinical Pharmacology & Therapeutics, 2023, v. 114, n. 3, p. 530, doi. 10.1002/cpt.2986
    By:
    • Mody, Hardik;
    • Ogasawara, Ken;
    • Zhu, Xu;
    • Miles, Dale;
    • Shastri, Prathap Nagaraja;
    • Gokemeijer, Jochem;
    • Liao, Michael Z.;
    • Kasichayanula, Sreeneeranj;
    • Yang, Tong‐Yuan;
    • Chemuturi, Nagendra;
    • Gupta, Swati;
    • Jawa, Vibha;
    • Upreti, Vijay V.
    Publication type:
    Article
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    Risk‐Based Pharmacokinetic and Drug–Drug Interaction Characterization of Antibody–Drug Conjugates in Oncology Clinical Development: An International Consortium for Innovation and Quality in Pharmaceutical Development Perspective.

    Published in:
    Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 4, p. 754, doi. 10.1002/cpt.2448
    By:
    • Li, Chunze;
    • Menon, Rajeev;
    • Walles, Markus;
    • Singh, Renu;
    • Upreti, Vijay V.;
    • Brackman, Deanna;
    • Lee, Anthony J.;
    • Endres, Christopher J.;
    • Kumar, Seema;
    • Zhang, Donglu;
    • Barletta, Frank;
    • Suri, Ajit;
    • Hainzl, Dominik;
    • Liao, Kai H.;
    • Lalovic, Bojan;
    • Beaumont, Maribel;
    • Zuo, Peiying;
    • Mayer, Andrew P.;
    • Wei, Dong
    Publication type:
    Article
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    Industrial Perspective on the Benefits Realized From the FDA's Model‐Informed Drug Development Paired Meeting Pilot Program.

    Published in:
    Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1172, doi. 10.1002/cpt.2265
    By:
    • Galluppi, Gerald R.;
    • Brar, Satjit;
    • Caro, Luzelena;
    • Chen, Yuan;
    • Frey, Nicolas;
    • Grimm, Hans Peter;
    • Rudd, Deanne Jackson;
    • Li, Chi‐Chung;
    • Magee, Mindy;
    • Mukherjee, Arnab;
    • Nagao, Lee;
    • Purohit, Vivek S.;
    • Roy, Amit;
    • Salem, Ahmed Hamed;
    • Sinha, Vikram;
    • Suleiman, Ahmed A.;
    • Taskar, Kunal S.;
    • Upreti, Vijay V.;
    • Weber, Benjamin;
    • Cook, Jack
    Publication type:
    Article
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    Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.

    Published in:
    Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 2, p. 297, doi. 10.1002/cpt.2125
    By:
    • Heimbach, Tycho;
    • Chen, Yuan;
    • Chen, Jun;
    • Dixit, Vaishali;
    • Parrott, Neil;
    • Peters, Sheila Annie;
    • Poggesi, Italo;
    • Sharma, Pradeep;
    • Snoeys, Jan;
    • Shebley, Mohamad;
    • Tai, Guoying;
    • Tse, Susanna;
    • Upreti, Vijay V.;
    • Wang, Ying‐Hong;
    • Tsai, Alice;
    • Xia, Binfeng;
    • Zheng, Ming;
    • Zhu, Andy Z.X.;
    • Hall, Stephen
    Publication type:
    Article
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    PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.

    Published in:
    AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00842-1
    By:
    • Kavita, Uma;
    • Sun, Kefeng;
    • Braun, Manuela;
    • Lembke, Wibke;
    • Mody, Hardik;
    • Kamerud, John;
    • Yang, Tong-Yuan;
    • Braun, Inka V.;
    • Fang, Xiaodong;
    • Gao, Wei;
    • Gupta, Swati;
    • Hofer, Magdalena;
    • Liao, Michael Z.;
    • Loo, LiNa;
    • McBlane, Fraser;
    • Menochet, Karelle;
    • Stubenrauch, Kay-Gunnar;
    • Upreti, Vijay V.;
    • Vigil, Adam;
    • Wiethoff, Christopher M.
    Publication type:
    Article
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    Safety, Tolerability, and Pharmacokinetics of a Capsule Formulation of DRF-1042, a Novel Camptothecin Analog, in Refractory Cancer Patients in a Bridging Phase I Study.

    Published in:
    Journal of Clinical Pharmacology, 2005, v. 45, n. 4, p. 453, doi. 10.1177/0091270004270225
    By:
    • Chatterjee, Arani;
    • Digumarti, Raghunadharao;
    • Katneni, Kasiram;
    • Upreti, Vijay V.;
    • Mamidi, Rao N. V. S.;
    • Mullangi, Ramesh;
    • Surath, Anjna;
    • Srinivas, Maddali L.;
    • Uppalapati, Srihari;
    • Jiwatani, Sangeeta;
    • Srinivas, Nuggehally R.
    Publication type:
    Article
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    Recommendations for the Design of Clinical Drug–Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically‐Based Pharmacokinetic Model.

    Published in:
    CPT: Pharmacometrics & Systems Pharmacology, 2019, v. 8, n. 9, p. 685, doi. 10.1002/psp4.12449
    By:
    • Chen, Yuan;
    • Cabalu, Tamara D.;
    • Callegari, Ernesto;
    • Einolf, Heidi;
    • Liu, Lichuan;
    • Parrott, Neil;
    • Peters, Sheila Annie;
    • Schuck, Edgar;
    • Sharma, Pradeep;
    • Tracey, Helen;
    • Upreti, Vijay V.;
    • Zheng, Ming;
    • Zhu, Andy Z.X.;
    • Hall, Stephen D.
    Publication type:
    Article
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