Lisa J. Benincosa
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View article: Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the <scp>ATR</scp> Inhibitor Tuvusertib
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the <span>ATR</span> Inhibitor Tuvusertib Open
We present model‐informed selection of the recommended dose for expansion (RDE) of investigational oral ATR inhibitor tuvusertib, by integrating clinical pharmacokinetics (PK), pharmacodynamics (PD), and safety data from DDRiver Solid Tumo…
View article: Sensitivity of Tepotinib to Inhibitors or Inducers of <scp>CYP3A4</scp> and P‐Gp: Drug Interaction Studies and Physiologically‐Based Pharmacokinetic Analysis
Sensitivity of Tepotinib to Inhibitors or Inducers of <span>CYP3A4</span> and P‐Gp: Drug Interaction Studies and Physiologically‐Based Pharmacokinetic Analysis Open
Tepotinib is a highly selective, potent, mesenchymal‐epithelial transition factor (MET) inhibitor, approved for the treatment of non‐small cell lung cancer harboring MET exon 14 skipping alterations. This work aimed to investigate the pote…
View article: Model‐based meta‐analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus
Model‐based meta‐analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus Open
Several investigational agents are under evaluation in systemic lupus erythematosus (SLE) clinical trials but quantitative frameworks to enable comparison of their efficacy to reference benchmark treatments are lacking. To benchmark SLE tr…
View article: Disease trajectory of <scp>SLE</scp> clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled <scp>patient‐level</scp> placebo (<scp>Standard‐of‐Care</scp>) data to enable <scp>model‐informed</scp> drug development
Disease trajectory of <span>SLE</span> clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled <span>patient‐level</span> placebo (<span>Standard‐of‐Care</span>) data to enable <span>model‐informed</span> drug development Open
Systemic lupus erythematosus (SLE) is an autoimmune disease affecting multiple organ systems. Many investigational agents have failed or shown only modest effects when added to standard of care (SoC) therapy in placebo‐controlled trials, a…
View article: Diversity and Inclusion in Drug Development: Rethinking Intrinsic and Extrinsic Factors with Patient Centricity
Diversity and Inclusion in Drug Development: Rethinking Intrinsic and Extrinsic Factors with Patient Centricity Open
Inadequate ethnic diversity in clinical trials, restrictive eligibility criteria, delayed or absent prescribing guidance for specific populations, and access lags impacting global health are under active discussion across academic, industr…
View article: Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities Open
View article: Challenges in Drug Development Posed by the COVID‐19 Pandemic: An Opportunity for Clinical Pharmacology
Challenges in Drug Development Posed by the COVID‐19 Pandemic: An Opportunity for Clinical Pharmacology Open
The unprecedented challenges posed by the coronavirus disease 2019 (COVID‐19) pandemic highlight the urgency for applying clinical pharmacology and model‐informed drug development in (i) dosage optimization for COVID‐19 therapies, (ii) app…