Objectives: The outcomes of SARS-CoV-2 infection exhibit considerable heterogeneity among individuals, with the diversity of these outcomes (asymptomatic, mild, severe,…
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Assessment of Sample Size Allocation for A Multi-regional Phase 2 Trial: Comparison of Statistical and Dose-Exposure-Response (D-E-R) Approaches
Introduction: Global simultaneous drug development has become a common practice in multinational pharmaceutical companies to reduce the time lag to…
Read moreTowards MIPD of Linezolid: External Evaluation of Population Pharmacokinetic Models
Objectives: Overdosing of linezolid increases the risk of adverse events such as thrombocytopenia, lactic acidosis, or neuropathy, while underdosing may…
Read moreIQReport: A Software Solution for Enhanced Report Generation Ensuring Workflow Efficiency, Traceability, and Reproducibility
Introduction/Objectives: Introducing the software solution IQReport, a software developed by IntiQuan, which aims to improve pharmacometric reporting. It enables the…
Read morePharmacokinetic-Pharmacodynamic Modelling of Risankizumab in Plaque Psoriasis Real World Data
Objectives: Risankizumab is an anti-interleukin (IL)-23 monoclonal antibody used in the treatment of plaque psoriasis. We sought to develop a…
Read morePreclinical population pharmacokinetic modelling of skin target site exposure of DNDI-0690 and DNDI-6148 in the treatment of cutaneous leishmaniasis
Introduction: Cutaneous Leishmaniasis (CL) represents the most common disease manifestation of the neglected tropical disease leishmaniasis, caused by various species of…
Read moreCombined population PK modelling of cefepime and enmetazobactam to characterize their individual and combined PK from the phase 1 to 3 studies
Introduction: Cefepime (FEP)-enmetazobactam (ENM) is a new fixed dose combination treatment for the treatment of urinary tract infections (cUTI) (and nosocomial…
Read moreA quantitative comparison of tumor sub-model variants in a minimal PBPK model for early clinical dose projections of antibody therapeutics in oncology
Objectives: In drug development, accurate prediction of clinical pharmacokinetics (PK) and pharmacologically active doses is imperative to decision-making at all…
Read moreA generic modeling framework for dose regimen optimization and patient selection in radioligand therapy
Introduction: The use of radioligand therapy (RLT) is gaining ground in oncology emerging as an essential pillar in cancer care,…
Read morePopulation PK and exposure-response modeling to support the design of trials with Debio 0123, a WEE1 inhibitor, in cancer patients
Introduction: Debio 0123 (D0123) is an oral, brain-penetrant, highly selective WEE1 inhibitor that has demonstrated significant cell growth inhibition in…
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