Introduction: The success of applications of Physiologically based pharmacokinetic (PBPK) modeling in drug development has led regulatory agencies to demand…
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PMx-AI Bot: Changing the way of traditional Pharmacometrics work with AI Bots
Objectives: The burgeoning influence of artificial intelligence (AI) is revolutionizing the field of pharmacometrics. This transformation is not only due…
Read morePopulation pharmacokinetics of intravenous MIT-001 in healthy subjects and patients
Objectives: MIT-001 is a potent mitochondrial-targeting antioxidant targeting various inflammatory diseases. Utilizing pharmacokinetic (PK) and safety data from previous clinical…
Read moreAging-related CYP3A functional changes: Novel findings from a model-based assessment of real-world pharmacokinetic study in Chinese older inpatients
Introduction: The conventional wisdom holds that oxidative CYP-mediated clearance would decrease with age, but some recent clinical trials refuted such…
Read moreA comparative analysis of Bayesian dose-finding designs incorporating pharmacokinetics information
Introduction: In most Phase I and Phase I/II studies in patients, dose-finding and pharmacokinetics/pharmacodynamics (PK/PD) are still analyzed separately [1]….
Read moreModelling the whole-body pharmacokinetics (WBPK) of radiolabeled glyburide in healthy volunteers
Introduction Microdosing approaches allow the administration of infra-therapeutic doses of drug candidates to humans. This approach, carried out upstream of…
Read moreA comparative benchmark study of empirical tumor size models in NSCLC clinical data
Introduction: Tumor size dynamics models are the key data analytics tools for analysis of the surrogate biomarker data in oncology…
Read moreCharacterizing the Longitudinal Exposure-Response Relationship of Upadacitinib Efficacy in Vitiligo: Insights from Analysis of Phase 2 Clinical Data
Introduction: Upadacitinib (UPA) is an orally administered Janus Kinase inhibitor which has been approved or is in development for the…
Read moreIn vitro-in silico platform for mechanistic investigation of bile acid disposition in cultured hepatocytes
Objectives: Drug-induced liver injury (DILI) is a relatively rare hepatic condition, yet the most frequent cause of acute liver failure in…
Read morePhysiologically-Based Pharmacokinetic Modeling of Extended-Release MK-2048 Formulations for HIV Pre-Exposure Prophylaxis in Non-Human Primates
Objectives: Human immunodeficiency virus (HIV) remains a significant global health challenge that disproportionately affects young women in sub-Saharan Africa [1]….
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