Search Results - "Cheung, S. Y. Amy"

Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network by Cucurull‐Sanchez, Lourdes, Chappell, Michael J., Chelliah, Vijayalakshmi, Amy Cheung, S. Y., Derks, Gianne, Penney, Mark, Phipps, Alex, Malik‐Sheriff, Rahuman S., Timmis, Jon, Tindall, Marcus J., Graaf, Piet H., Vicini, Paolo, Yates, James W. T.

“…The lack of standardization in the way that quantitative and systems pharmacology (QSP) models are developed, tested, and documented hinders their…”
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Characterization of the disposition of fostamatinib in Japanese subjects including pharmacokinetic assessment in dry blood spots: results from two phase I clinical studies by Martin, Paul, Cheung, S. Y. Amy, Yen, Mark, Han, David, Gillen, Michael

“…Purpose The aims of the present study were to characterize the pharmacokinetics of fostamatinib in two phase I studies in healthy Japanese subjects after…”
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Ceralasertib (AZD6738), an Oral ATR Kinase Inhibitor, in Combination with Carboplatin in Patients with Advanced Solid Tumors: A Phase I Study by Yap, Timothy A, Krebs, Matthew G, Postel-Vinay, Sophie, El-Khouiery, Anthony, Soria, Jean-Charles, Lopez, Juanita, Berges, Alienor, Cheung, S Y Amy, Irurzun-Arana, Itziar, Goldwin, Andrew, Felicetti, Brunella, Jones, Gemma N, Lau, Alan, Frewer, Paul, Pierce, Andrew J, Clack, Glen, Stephens, Christine, Smith, Simon A, Dean, Emma, Hollingsworth, Simon J

“…This study reports the safety, tolerability, MTD, recommended phase II dose (RP2D), pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity…”
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Proliferation and AKT Activity Biomarker Analyses after Capivasertib (AZD5363) Treatment of Patients with ER + Invasive Breast Cancer (STAKT) by Robertson, John F R, Coleman, Robert E, Cheung, Kwok-Leung, Evans, Abigail, Holcombe, Chris, Skene, Anthony, Rea, Daniel, Ahmed, Samreen, Jahan, Ali, Horgan, Kieran, Rauchhaus, Petra, Littleford, Roberta, Cheung, S Y Amy, Cullberg, Marie, de Bruin, Elza C, Koulai, Loumpiana, Lindemann, Justin P O, Pass, Martin, Rugman, Paul, Schiavon, Gaia, Deb, Rahul, Finlay, Pauline, Foxley, Andrew, Gee, Julia M W

“…The STAKT study examined short-term exposure (4.5 days) to the oral selective pan-AKT inhibitor capivasertib (AZD5363) to determine if this drug can reach its…”
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Industry Perspective on Using MIDD for Pediatric Studies Requiring Integration of Ontogeny by Corriol‐Rohou, Solange, Cheung, S. Y. Amy

“…Joining the Food and Drug Administration/University of Maryland Center of Excellence in Regulatory Science and Innovation Workshop to discuss and identify…”
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Cost effectiveness analyses of pharmacological treatments in heart failure by Lim, Audrey Huili, Abdul Rahim, Nusaibah, Zhao, Jinxin, Cheung, S. Y. Amy, Lin, Yu-Wei

“…In a rapidly growing and aging population, heart failure (HF) has become recognised as a public health concern that imposes high economic and societal costs…”
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Artificial Intelligence and Machine Learning Applied at the Point of Care by Angehrn, Zuzanna, Haldna, Liina, Zandvliet, Anthe S, Gil Berglund, Eva, Zeeuw, Joost, Amzal, Billy, Cheung, S Y Amy, Polasek, Thomas M, Pfister, Marc, Kerbusch, Thomas, Heckman, Niedre M

“…The increasing availability of healthcare data and rapid development of big data analytic methods has opened new avenues for use of Artificial Intelligence…”
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Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019 by Khong, Yuet Mei, Liu, Jing, Cook, Jack, Purohit, Vivek, Thompson, Karen, Mehrotra, Shailly, Cheung, S.Y. Amy, Hay, Justin L., Fletcher, Elimika Pfuma, Wang, Jian, Sachs, Hari Cheryl, Zhu, Hao, Siddiqui, Akhtar, Cunningham, Lea, Selen, Arzu

“…[Display omitted] A pediatric formulation workshop entitled “Pediatric Formulations: Challenges of Today and Strategies for Tomorrow” was held to advance…”
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Pediatric oncology drug development and dosage optimization by Cheung, S Y Amy, Hay, Justin L, Lin, Yu-Wei, de Greef, Rik, Bullock, Julie

“…Oncology drug discovery and development has always been an area facing many challenges. Phase 1 oncology studies are typically small, open-label, sequential…”
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Editorial: Model-informed drug development and evidence-based translational pharmacology by Zhao, Jinxin, Zhu, Xiao, Tan, Songwen, Chen, Chuanpin, Kaddoumi, Amal, Guo, Xiu-Li, Lin, Yu-Wei, Cheung, S Y Amy

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Epstein-Barr Virus Reactivation After Paediatric Haematopoietic Stem Cell Transplantation: Risk Factors and Sensitivity Analysis of Mathematical Model by Kania, Soumya P, Silva, Juliana M F, Charles, Oscar J, Booth, John, Cheung, S Y Amy, Yates, James W T, Worth, Austen, Breuer, Judith, Klein, Nigel, Amrolia, Persis J, Veys, Paul, Standing, Joseph F

“…Epstein-Barr virus (EBV) establishes a lifelong latent infection in healthy humans, kept under immune control by cytotoxic T cells (CTLs). Following paediatric…”
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V2ACHER: Visualization of complex trial data in pharmacometric analyses with covariates by Lommerse, Jos, Plock, Nele, Cheung, S. Y. Amy, Sachs, Jeffrey R.

“…Pharmacometric models can enhance clinical decision making, with covariates exposing potential contributions to variability of subpopulation characteristics,…”
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The design and analysis of parallel experiments to produce structurally identifiable models by Cheung, S. Y. Amy, Yates, James W. T., Aarons, Leon

“…Pharmacokinetic analysis in humans using compartmental models is restricted with respect to the estimation of parameter values. This is because the…”
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Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group‐Pediatrics Working Group, Rare Diseases Subteam Whitepaper Examining the Current Landscape and Recommendations for the Future by Krishna, Rajesh, Sebastien, Bernard, Corriol‐Rohou, Solange, Cheung, S. Y. Amy, Liu, Jing, Suryawanshi, Satyendra

“…Many new opportunities surround rare pediatric disease drug development, thanks to key advances in regulatory thinking and in the scientific community. As rare…”
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Supporting Prospective Pregnancy Trials via Modeling and Simulation: Lessons From the Past and Recommendations for the Future by Cheung, S. Y. Amy, Barrett, Jeffrey S.

“…Despite the increasing awareness and guidance to support drug research and development in the pregnant population, there is still a high unmet medical need and…”
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Predictive Performance of Physiologically Based Pharmacokinetic (PBPK) Modeling of Drugs Extensively Metabolized by Major Cytochrome P450s in Children by Zhou, Wangda, Johnson, Trevor N., Bui, Khanh H., Cheung, S.Y. Amy, Li, Jianguo, Xu, Hongmei, Al‐Huniti, Nidal, Zhou, Diansong

“…The accuracy of physiologically based pharmacokinetic (PBPK) model prediction in children, especially those younger than 2 years old, has not been…”
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Concentration‐QT modelling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations by Voronova, Veronika, Cullberg, Marie, Delff, Philip, Parkinson, Joanna, Dota, Corina, Schiavon, Gaia, Maroj, Brijesh, Rekić, Dinko, Cheung, S. Y. Amy

“…Pharmacokinetics‐matched digital electrocardiogram data (n = 503 measurements from 180 patients) collected in a first‐in‐human, multi‐part, dose‐escalation…”
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Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment by Musuamba, Flora T., Cheung, S.Y. Amy, Colin, Pieter, Davies, Elin H., Barret, Jeffrey S., Pappalardo, Francesco, Chappell, Michael, Dogne, Jean‐Michel, Ceci, Adriana, Della Pasqua, Oscar, Rusten, Ine S.

“…The most intuitive question for market access for medicinal products is the benefit/risk (B/R) balance. The B/R assessment can conceptually be divided into…”
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Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials by Sebastien, Bernard, Cheung, S. Y. Amy, Corriol-Rohou, Solange, Gamalo-Siebers, Margaret, Jreich, Rana, Krishna, Rajesh, Liu, Jing

“…The use of Bayesian methodology to design and analyze pediatric efficacy trials is one of the possible options to reduce their sample size. This reduction of…”
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Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop by Barrett, Jeffrey S., Bucci‐Rechtweg, Christina, Amy Cheung, S. Y., Gamalo‐Siebers, Margaret, Haertter, Sebastian, Karres, Janina, Marquard, Jan, Mulugeta, Yeruk, Ollivier, Cecile, Strougo, Ashley, Yanoff, Lisa, Yao, Lynne, Zeitler, Philip

“…Extrapolation from adults to youth with type 2 diabetes (T2D) is challenged by differences in disease progression and manifestation. This manuscript presents…”
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