Works matching IS 15507416 AND DT 2023 AND VI 25 AND IP 4

Results: 21
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    Neutralizing Antibody Validation Testing and Reporting Harmonization.

    Published in:
    AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00830-5
    By:
    • Myler, Heather;
    • Pedras-Vasconcelos, João;
    • Lester, Todd;
    • Civoli, Francesca;
    • Xu, Weifeng;
    • Wu, Bonnie;
    • Vainshtein, Inna;
    • Luo, Linlin;
    • Hassanein, Mohamed;
    • Liu, Susana;
    • Ramaswamy, Swarna Suba;
    • Mora, Johanna;
    • Pennucci, Jason;
    • McCush, Fred;
    • Lavelle, Amy;
    • Jani, Darshana;
    • Ambakhutwala, Angela;
    • Baltrukonis, Daniel;
    • Barker, Breann;
    • Carmean, Rebecca
    Publication type:
    Article
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    Mini-PBPK-Based Population Model and Covariate Analysis to Assess the Complex Pharmacokinetics and Pharmacodynamics of RO7449135, an Anti-KLK5/KLK7 Bispecific Antibody in Cynomolgus Monkeys.

    Published in:
    AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00829-y
    By:
    • Cai, Hao;
    • Tao, Xun;
    • Shim, Jeongsup;
    • Bauer, Rebecca N.;
    • Bremer, Meire;
    • Bu, Wei;
    • LaMar, Jason;
    • Basile, Rachel;
    • Dere, Edward;
    • Nguyen, Tien;
    • Laing, Steven;
    • Chan, Pamela;
    • Yi, Tangsheng;
    • Koerber, James T.;
    • Sperinde, Gizette;
    • Stefanich, Eric
    Publication type:
    Article
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    Correction: Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets.

    Published in:
    2023
    By:
    • Tsume, Yasuhiro;
    • Ashworth, Lee;
    • Bermejo, Marival;
    • Cheng, Joan;
    • Cicale, Vincent;
    • Dressman, Jennifer;
    • Fushimi, Masahiro;
    • Gonzalez-Alvarez, Isabel;
    • Guo, Yiwang;
    • Jankovsky, Corinne;
    • Lu, Xujin;
    • Matsui, Kazuki;
    • Patel, Sanjaykumar;
    • Sanderson, Natalie;
    • Sun, Changquan Calvin;
    • Thakral, Naveen K.;
    • Yamane, Miki;
    • Zöller, Laurin
    Publication type:
    Correction Notice
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    Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis.

    Published in:
    AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00822-5
    By:
    • Kesisoglou, Filippos;
    • Basu, Sumit;
    • Belubbi, Tejashree;
    • Bransford, Philip;
    • Chung, John;
    • Dodd, Stephanie;
    • Dolton, Michael;
    • Heimbach, Tycho;
    • Kulkarni, Priyanka;
    • Lin, Wen;
    • Moir, Andrea;
    • Parrott, Neil;
    • Pepin, Xavier;
    • Ren, Xiaojun;
    • Sharma, Pradeep;
    • Stamatopoulos, Konstantinos;
    • Tistaert, Christophe;
    • Vaidhyanathan, Shruthi;
    • Wagner, Christian;
    • Riedmaier, Arian Emami
    Publication type:
    Article
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    Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.

    Published in:
    AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00820-7
    By:
    • Gokemeijer, Jochem;
    • Wen, Yi;
    • Jawa, Vibha;
    • Mitra-Kaushik, Shibani;
    • Chung, Shan;
    • Goggins, Alan;
    • Kumar, Seema;
    • Lamberth, Kasper;
    • Liao, Karen;
    • Lill, Jennie;
    • Phung, Qui;
    • Walsh, Robin;
    • Roberts, Brian J.;
    • Swanson, Michael;
    • Singh, Inderpal;
    • Tourdot, Sophie;
    • Kroenke, Mark A.;
    • Rup, Bonita;
    • Goletz, Theresa J.;
    • Gupta, Swati
    Publication type:
    Article
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