Background Hydroxyurea (HU) is the standard disease-modifying therapy for sickle cell disease (SCD), improving survival and reducing vaso-occlusive complications through…
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Isatuximab SC versus IV in patients with Relapsed/Refractory Multiple Myeloma: Insights from longitudinal PK/PD Analysis of Serum M-Protein in the non-inferiority IRAKLIA Trial
Introduction: The subcutaneous (SC) formulation of isatuximab (Isa) combined with pomalidomide and dexamethasone (Pd) demonstrated non-inferiority to Isa intravenous (IV)…
Read moreQUANTITATIVE DIFFERENCES IN TRENDS OF INFLAMMATORY BIOMARKERS IN PREGNANT AND POSTPARTUM INDIVIDUALS WITH AND WITHOUT INFLAMMATORY BOWEL DISEASE
Introduction: Pregnancy involves major physiological changes that can alter dynamics of biomarkers commonly used in pre-pregnancy[1–3]. Among these, C-reactive protein…
Read moreTranslational Modeling Based on a Semi-Mechanistic Target-Mediated Drug Disposition (TMDD) Approach
Objectives: ABO21009 is a humanized IgG1 monoclonal antibody targeting human CD45RC, currently developed for the treatment of rheumatoid arthritis. The…
Read moreImpact of soluble BCMA on the PKPD assessment and dose selection for BCMA 4-1BBL
Introduction: BCMA 4-1BBL is a costimulatory molecule designed to enhance T-cell engager efficacy in multiple myeloma (MM). Its bispecific binding…
Read morePredicting Receptor Occupancy via Empirical Approximations from Nonlinear Population PK Modeling
Objectives Assessing monoclonal antibody target engagement in vivo is critical to understanding drug activity and informing the selection of a…
Read moreMACHINE LEARNING-BASED COVARIATE SELECTION IN POPULATION PHARMACOKINETICS: A SYSTEMATIC EVALUATION OF BORUTA ALGORITHM WITH TREE-BASED METHODS AGAINST SCM+
Introduction Stepwise covariate modeling (SCM) [1] is the most widely used method for covariate selection. An improved version (called SCM+)…
Read morePrediction of Hydroxyurea Pharmacokinetics and Dose Adjustment in Children with Mild, Moderate, and Severe Renal Impairment Using Physiologically Based Pharmacokinetic Modeling
Background Hydroxyurea is the cornerstone disease-modifying therapy for sickle cell disease (SCD) in pediatric populations. Kidney involvement is a recognized…
Read moreDevelopment of a physiologically-based pharmacokinetic model to characterize the drug-drug interaction of the inhaled compound CHF6001 as a victim of CYP3A4 inhibitors
Objectives: CHF6001 is a PDE4 inhibitor that was specifically designed to be delivered via inhalation [1]. In vitro data showed…
Read moreTEZEPELUMAB POPULATION PHARMACOKINETICS SUPPORTS PAEDIATRIC EXTRAPOLATION IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS (CRSwNP)
Introduction/Objectives: Tezepelumab (210 mg subcutaneously [SC] every 4 weeks [Q4W]) is approved in several markets worldwide as an add-on maintenance…
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