Quantification of drug metabolising enzymes and transporter proteins in the paediatric duodenum via LC-MS/MS proteomics using a QconCAT technique Publication Quantification of drug metabolising enzymes and transporter proteins in the paediatric duodenum via LC-MS/MS proteomics using a QconCAT technique Characterising the small intestine absorptive membrane is essential to enable prediction of the systemic exposure…Danielle Pillsbury2023年8月29日
Development and Verification of a Japanese Pediatric Physiologically Based Pharmacokinetic Model with Emphasis on Drugs Eliminated by Cytochrome P450 or Renal Excretion Publication Development and Verification of a Japanese Pediatric Physiologically Based Pharmacokinetic Model with Emphasis on Drugs Eliminated by Cytochrome P450 or Renal Excretion Physiologically based pharmacokinetic (PBPK) models are useful in bridging drug exposure in different ethnic groups,…Jim Gallagher2023年8月21日
Development and application of a PBPK modeling strategy to support antimalarial drug development Publication Development and application of a PBPK modeling strategy to support antimalarial drug development As part of a collaboration between Medicines for Malaria Venture (MMV), Certara UK and Monash…Jim Gallagher2023年8月18日
Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases Publication Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases Successful clinical development of new therapeutic interventions is notoriously difficult, especially in neurodegenerative diseases, where…Danielle Pillsbury2023年8月15日
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling Publication Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration…Danielle Pillsbury2023年7月21日
Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome Publication Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome Madin–Darby canine kidney (MDCK) cells are widely used to study epithelial cell functionality. Their low…Danielle Pillsbury2023年6月28日
Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper Publication Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper The promise of viral vector-based gene therapy (GT) as a transformative paradigm for treating severely…Danielle Pillsbury2023年6月14日
QSP Designer: Quantitative systems pharmacology modeling with modular biological process map notation and multiple language code generation Publication QSP Designer: Quantitative systems pharmacology modeling with modular biological process map notation and multiple language code generation Typical Quantitative Systems Pharmacology (QSP) workflows involve discussion of biology, supported by graphical diagrams, followed…Danielle Pillsbury2023年5月25日
Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma Publication Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma An novel single dose regimen of tremelimumab combined with durvalumab could be a way to…Rajesh Krishna2023年1月26日
ScienceDirect: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial Publication ScienceDirect: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial Observational studies have postulated a therapeutic role of metformin in treating COVID-19. We conducted ...(cont.)Jim Gallagher2021年12月22日