Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations Publication Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations This mini-review provides a concise and comprehensive overview of the pregnancy PBPK field and identify…Jim Gallagher2024年1月3日
A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy Publication A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy This comprehensive review exposes gaps in current knowledge of phase II enzyme and drug transporter…Jim Gallagher2024年1月3日
Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy Publication Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy For drugs highly bound to plasma proteins, changes in concentrations of free drug may have…Jim Gallagher2024年1月3日
Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials Publication Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…Jim Gallagher2023年12月19日
Model-informed target identification and validation through combining quantitative systems pharmacology with network-based analysis Publication Model-informed target identification and validation through combining quantitative systems pharmacology with network-based analysis Authors: Vijayalakshmi Chelliah, Piet H. van der Graaf One of the main areas where quantitative…Jim Gallagher2023年11月28日
Creation of novel sensitive probe substrate and moderate inhibitor models for a comprehensive prediction of CYP2C8 interactions for tucatinib Publication Creation of novel sensitive probe substrate and moderate inhibitor models for a comprehensive prediction of CYP2C8 interactions for tucatinib Authors: Ian E. Templeton, Karen Rowland-Yeo, Hannah M. Jones, Christopher J. Endres, Ariel R. Topletz-Erickson, Hao Sun, Anthony J. Lee A…Jim Gallagher2023年11月28日
A quantitative clinical pharmacology-based framework for model-informed vaccine development Publication A quantitative clinical pharmacology-based framework for model-informed vaccine development Historically, vaccine development and dose optimization have followed mostly empirical approaches without clinical pharmacology and…Jim Gallagher2023年11月20日
No Recipe for Quantitative Systems Pharmacology Model Validation, but a Balancing Act Between Risk and Cost Publication No Recipe for Quantitative Systems Pharmacology Model Validation, but a Balancing Act Between Risk and Cost Quantitative systems pharmacology (QSP) models generate predictions by formalizing biological understanding and integrating multiscale data,…Jim Gallagher2023年11月16日
Regulatory initiatives for artificial intelligence applications: Regulatory writing implications Publication 人工知能アプリケーションに対する規制の取り組み:レギュラトリーライティングへの影響 メディカルライティング | Volume 32, Issue 3 - Artificial Intelligence and Machine LearningAuthor: Anjana Bose…Danielle Pillsbury2023年10月11日
Analysis of clinical failure of anti-tau and anti-synuclein antibodies in neurodegeneration using a quantitative systems pharmacology model Publication Analysis of clinical failure of anti-tau and anti-synuclein antibodies in neurodegeneration using a quantitative systems pharmacology model Hugo Geerts, Silke Bergeler, Mike Walker, Piet van der Graaf, Jean-Philippe Courade. Sci Rep. 2023…Danielle Pillsbury2023年10月5日