Search Results - "drug development"

Digital Research Environment(DRE)-enabled Artificial Intelligence (AI) to facilitate early stage drug development by Jeffrey S. Barrett, Solmaz Eradat Oskoui, Scott Russell, Amanda Borens

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Expanding Role of Endogenous Biomarkers for Assessment of Transporter Activity in Drug Development: Current Applications and Future Horizon by Vikram Arya, Joseph D. Ma, Kine Eide Kvitne

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Power Determination During Drug Development: Is Optimizing the Sample Size Based on Exposure‐Response Analyses Underutilized? by Aksana K. Jones, Ahmed Hamed Salem, Kevin J. Freise

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Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges by Flora T. Musuamba, Roberta Bursi, Efthymios Manolis, Kristin Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Raphaëlle Lesage, Cécile Crozatier, Emmanuelle M. Voisin, Cécile F. Rousseau, Thierry Marchal, Rossana Alessandrello, Liesbet Geris

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Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children by Andrew E. Mulberg, MD, FAAP, Timothy Cripps, MSc

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Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility by Flora T. Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi, Luca Emili, Gaby Wangorsch, Efthymios Manolis, Kristin E. Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Cécile F. Rousseau, Emmanuelle M. Voisin, Rossana Alessandrello, Nuno Curado, Enrico Dall'ara, Blanca Rodriguez, Francesco Pappalardo, Liesbet Geris

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Model‐informed drug development of voxelotor in sickle cell disease: Population pharmacokinetics in whole blood and plasma by Radojka M. Savic, Michelle L. Green, Karin Jorga, Michael Zager, Carla B. Washington

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Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies by Rajiv Mahajan, Kapil Gupta

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Transition to the Non-Clinical Drug Development Principles and Rules of the Eurasian Economic Union: Changes, Challenges, and Prospects by A. A. Spasov

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Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine by André Dallmann, Peter L. Bonate, Janelle Burnham, Blessy George, Lynne Yao, Jane Knöchel

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Exploratory Analysis of the Factors Associated With Success Rates of Confirmatory Randomized Controlled Trials in Cancer Drug Development by Can Wu, Shunsuke Ono

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Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities by Nidal Al‐Huniti, Yan Feng, Jingyu (Jerry), Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng

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Genetic Diversity and Disease Susceptibility

Subjects: “…cancer, pharmacogenetics, polymorphisms, molecular markers, drug development, pharmacokinetics…”
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Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development by Karim Azer, Jeffrey S. Barrett

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Nano-Hydroxyapatite/PLGA Mixed Scaffolds as a Tool for Drug Development and to Study Metastatic Prostate Cancer in the Bone by Annachiara Dozzo, Krishnakumar Chullipalliyalil, Michael McAuliffe, Caitriona M. O'Driscoll, Katie B. Ryan

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Potassium homeostasis and therapeutic intervention with sodium zirconium cyclosilicate: A model‐informed drug development case study by Lindsay E. Clegg, Lulu Chu, Mats Nagard, David W. Boulton, Robert C. Penland

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Combined quantitative tuberculosis biomarker model for time-to-positivity and colony forming unit to support tuberculosis drug development by Rami Ayoun Alsoud, Robin J. Svensson, Elin M. Svensson, Elin M. Svensson, Stephen H. Gillespie, Martin J. Boeree, Andreas H. Diacon, Rodney Dawson, Rodney Dawson, Rob E. Aarnoutse, Ulrika S. H. Simonsson

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Antimalarial efficacy and toxicological assessment of medicinal plant ingredients of Prabchompoothaweep remedy as a candidate for antimalarial drug development by Prapaporn Chaniad, Tachpon Techarang, Arisara Phuwajaroanpong, Walaiporn Plirat, Parnpen Viriyavejakul, Abdi Wira Septama, Chuchard Punsawad

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A Physiology-Based Pharmacokinetic Framework to Support Drug Development and Dose Precision During Therapeutic Hypothermia in Neonates by Anne Smits, Anne Smits, Pieter Annaert, Steven Van Cruchten, Karel Allegaert, Karel Allegaert, Karel Allegaert

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PknB remains an essential and a conserved target for drug development in susceptible and MDR strains of M. Tuberculosis by Anamika Gupta, Sudhir K. Pal, Divya Pandey, Najneen A. Fakir, Sunita Rathod, Dhiraj Sinha, S. SivaKumar, Pallavi Sinha, Mycal Periera, Shilpa Balgam, Gomathi Sekar, K. R. UmaDevi, Shampa Anupurba, Vijay Nema

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