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PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus
Szeto, Ke Xu, Le Merdy, Maxime, Dupont, Benjamin, Bolger, Michael B., Lukacova, Viera
Published in The AAPS journal (24.06.2021)
Published in The AAPS journal (24.06.2021)
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ICH M12 Drug Interaction Studies: Summary of the Efforts to Achieve Global Convergence
Reynolds, Kellie, Yang, Xinning, Peters, Sheila Annie, Sinha, Vikram, Heymann, Helen, Borges, Luiza Novaes, Einolf, Heidi J, Fu, Shujun, Hoshino, Motohiro, Li, Li, Lindhagen, Elin, Miyoshi, So, Mizuno, Katsuhiko, Pilla Reddy, Venkatesh, Roost, Matthias S, Shigemi, Ryota, Tao, Xiaolu, Yang, Meng-Syuan, Zhao, Sylvia, Versantvoort, Carolien, Ishiguro, Akihiro, Madabushi, Rajanikanth
Published in Clinical pharmacology and therapeutics (01.07.2025)
Published in Clinical pharmacology and therapeutics (01.07.2025)
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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration
Green, Dionna J, Liu, Xiaomei I, Hua, Tianyi, Burnham, Janelle M, Schuck, Robert, Pacanowski, Michael, Yao, Lynne, McCune, Susan K, Burckart, Gilbert J, Zineh, Issam
Published in Clinical pharmacology and therapeutics (01.11.2018)
Published in Clinical pharmacology and therapeutics (01.11.2018)
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Creatinine-Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs
Zhang, Yifei, Sherwin, Catherine M, Gonzalez, Daniel, Zhang, Qunshu, Khurana, Mona, Fisher, Jeffrey, Burckart, Gilbert J, Wang, Yaning, Yao, Lynne P, Ganley, Charles J, Wang, Jian
Published in Clinical pharmacology and therapeutics (01.01.2021)
Published in Clinical pharmacology and therapeutics (01.01.2021)
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Discovery and Model-Informed Drug Development of a Controlled-Release Formulation of Nonracemic Amisulpride that Reduces Plasma Exposure but Achieves Pharmacodynamic Bioequivalence in the Brain
Hopkins, Seth C, Toongsuwan, Siriporn, Corriveau, Taryn J, Watanabe, Takao, Tsushima, Yuki, Asada, Takumi, Lew, Robert, Shi, Lei, Zann, Vanessa, Snowden, Thomas J, van der Graaf, Piet H, Darpo, Borje, Searle, Graham E, Rabiner, Eugenii A, Wilding, Ian, Szabo, Steven T, Galluppi, Gerald R, Koblan, Kenneth S
Published in Clinical pharmacology and therapeutics (01.08.2024)
Published in Clinical pharmacology and therapeutics (01.08.2024)
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Revolutionizing Patient-Reported Outcomes Analysis for Oncology Drug Development Using Population Models
Zhou, Jiawei, Muluneh, Benyam, Li, Quefeng, Hughes, Jim H.
Published in Clinical cancer research (01.05.2025)
Published in Clinical cancer research (01.05.2025)
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Biochemical features and mutations of key proteins in SARS-CoV-2 and their impacts on RNA therapeutics
Zeng, Li, Li, Dongying, Tong, Weida, Shi, Tieliu, Ning, Baitang
Published in Biochemical pharmacology (01.07.2021)
Published in Biochemical pharmacology (01.07.2021)
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Biopharmaceutic IVIVE—Mechanistic Modeling of Single- and Two-Phase In Vitro Experiments to Obtain Drug-Specific Parameters for Incorporation Into PBPK Models
Pathak, Shriram M., Schaefer, Kerstin Julia, Jamei, Masoud, Turner, David B.
Published in Journal of pharmaceutical sciences (01.04.2019)
Published in Journal of pharmaceutical sciences (01.04.2019)
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Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions
Sharma, Vishnu Dutt, Bhattaram, Venkatesh Atul, Krudys, Kevin, Li, Zhihua, Marathe, Anshu, Mehrotra, Nitin, Wang, Xiaofeng, Liu, Jiang, Stier, Ethan, Florian, Jeffry, Madabushi, Raj, Zhu, Hao
Published in Journal of clinical pharmacology (01.12.2024)
Published in Journal of clinical pharmacology (01.12.2024)
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Prion protein quantification in human cerebrospinal fluid as a tool for prion disease drug development
Vallabh, Sonia M., Nobuhara, Chloe K., Llorens, Franc, Zerr, Inga, Parchi, Piero, Capellari, Sabina, Kuhn, Eric, Klickstein, Jacob, Safar, Jiri G., Nery, Flavia C., Swoboda, Kathryn J., Geschwind, Michael D., Zetterberg, Henrik, Arnold, Steven E., Minikel, Eric Vallabh, Schreiber, Stuart L.
Published in Proceedings of the National Academy of Sciences - PNAS (16.04.2019)
Published in Proceedings of the National Academy of Sciences - PNAS (16.04.2019)
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Optimization of a drug transporter probe cocktail: potential screening tool for transporter‐mediated drug–drug interactions
Stopfer, Peter, Giessmann, Thomas, Hohl, Kathrin, Hutzel, Sabine, Schmidt, Sven, Gansser, Dietmar, Ishiguro, Naoki, Taub, Mitchell E., Sharma, Ashish, Ebner, Thomas, Müller, Fabian
Published in British journal of clinical pharmacology (01.09.2018)
Published in British journal of clinical pharmacology (01.09.2018)
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Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis
Vazvaei-Smith, Faye, Li, Wenkui, Barnaby, Omar S., Bhardwaj, Sanjeev, Dong, Juyao, Dumont, Carolyne, Fernández-Metzler, Carmen, Geist, Brian, Hassanein, Mohamed, Hays, Amanda, Ilinskaya, Anna, Kadar, Eugene P., King, Kris, Kulagina, Nadia, Matta, Murali K., Midde, Krishna, Pan, Rina, Pathania, Divya, Tarnowski, Thomas, Tewalt, Eric, Thomas, Eric, Wickremsinhe, Enaksha, Xiao, Deqing
Published in The AAPS journal (11.03.2025)
Published in The AAPS journal (11.03.2025)
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Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review
Mao, Bingyu, Gao, Yue, Xu, Christine, Macha, Sreeraj, Shao, Shuai, Ahamadi, Malidi
Published in The AAPS journal (02.06.2025)
Published in The AAPS journal (02.06.2025)
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