Bispecific T-cell engagers (TCEs) offer potent therapeutic benefits, yet their clinical translation is frequently hindered by non-linear pharmacokinetics and severe…
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Population Pharmacokinetics of Dolutegravir with Daily Rifapentine for HIV-associated Tuberculosis
Objectives: Dolutegravir remains a key component of first-line antiretroviral therapy in settings with a high burden of HIV and tuberculosis…
Read moreCharacterization and comparison of absorption profiles between three novel sustained-release formulations of oral flucytosine for cryptococcal meningitis treatment through population pharmacokinetic modeling
Objectives: Cryptococcal meningitis (CM) is a fungal infection of the central nervous system characterized by inflammation of the meninges. It…
Read moreComparison of an uncertainty-based dynamical SCM-ML approach with classical covariate model building techniques
Objective Covariate model building (CMB) remains one of the most time-consuming and decision-intensive steps in population pharmacokinetic (popPK) modeling. Stepwise…
Read moreTMDD modeling for antibodies directed against soluble targets: parameter values for de novo modeling and simulation from experimental data.
Objectives: Target mediated drug disposition (TMDD) models are widely used to describe monoclonal antibody pharmacokinetics and to predict suppression of…
Read moreAn Item Response Theory-Based Comparison of Multiple Versions of SARA Rating Assessment of Degenerative Ataxia in a SCA3 Cohort
Background: Spinocerebellar Ataxia (SCA) is a heterogeneous group of rare autosomal-dominant progressive diseases that affect gait, balance, and limb coordination…
Read moreThe hybrid AI/ML – Pharmacometrics Communications Cheat Sheet
Objectives Hybrid AI/ML-pharmacometrics approaches are increasingly discussed for drug development [1], but productive collaboration is often slowed by terminology gaps…
Read moreEnhancing Data Sharing and Anonymization to Enable Model-Based Approaches and Virtual Patient Cohorts in the INVENTS Project
Objectives: Drug development in rare diseases and paediatrics is challenging due to limited disease understanding, small sample sizes, single-arm trials…
Read moreModel-Based Quantification of Soluble CEACAM5 Impact on the Pharmacokinetics of A T-Cell Bispecific Antibody to Inform Clinical Decisions
INTRODUCTION T cell–redirecting bispecific antibodies (TCBs) targeting CEACAM5 are being developed as a therapeutic in colorectal cancer (CRC) [1]. CEACAM5…
Read moreValidation and refinement of the large molecule biodistribution model in PK-Sim.
Background: The predictive performance of the PK-Sim large molecule biodistribution model has been publicly evaluated on a dataset from 8…
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