Introduction: In bioequivalence trials, regulatory authorities recommend testing average bioequivalence (ABE) between a test (T) and a reference (R) product…
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TRANSLATIONAL PKPD MODELLING FRAMEWORK TO SUPPORT PRIORITISATION OF NOVEL TUBERCULOSIS REGIMENS WITHIN THE PARADIGM4TB PLATFORM.
Introduction: The development of novel tuberculosis (TB) combination regimens is constrained by long, resource-intensive clinical trials and limited quantitative evaluation…
Read moreINTERPRETABLE MACHINE LEARNING-BASED DECISION SUPPORT FOR POPULATION PHARMACOKINETIC DIAGNOSTICS UNDER REALISTIC SHRINKAGE AND SPARSITY CONDITIONS
Introduction Model development in population pharmacokinetics is inherently iterative and largely guided by qualitative interpretation of diagnostic plots and fit…
Read moreDevelopment and Evaluation of an Optimized Busulfan Dosing Strategy in Hematopoietic Stem Cell Transplantation
Introduction: Busulfan is a cornerstone of conditioning regimens prior to hematopoietic stem cell transplantation (HCT). It has a narrow therapeutic…
Read moreEFFECT OF METFORMIN ON THE PHARMACOKINETICS OF RIFAMPICIN, ISONIAZID, AND PYRAZINAMIDE IN ADULTS WITH TB AND HIV
Objective Tuberculosis (TB) remains the leading infectious cause of death, particularly among people with HIV (1,2). Metformin is being investigated…
Read morePaediatric pharmacokinetic studies could be optimized for the precision of the clinically relevant exposure endpoint instead of PK parameter precision
Introduction: During drug development, sponsors are generally required to study their drug candidate in children. Sometimes the drug’s benefit-risk balance…
Read moreModel-based assessment of isatuximab monthly dosing regimen in relapsed/refractory multiple myeloma patients using IKEMA phase 3 data
Objectives: Carfilzomib and dexamethasone (Kd) is an effective treatment option for patients with relapsed/refractory multiple myeloma (RRMM). The addition of…
Read moreModelling home-measured peak expiratory flow using a mixed-effects hidden Markov model: An alternative approach to quantifying treatment effects in asthma
Objectives Lung function of people with asthma fluctuates substantially over time, and increased variability has been linked to elevated risk…
Read moreMODEL-BASED META-ANALYSIS TO INFORM CHRONIC KIDNEY DISEASE DRUG DEVELOPMENT
Introduction/ Objectives: Chronic kidney disease (CKD) represents a significant unmet medical need, with diverse aetiologies and disease severities requiring tailored…
Read moreDevelopment of averaged population pharmacokinetic model of vancomycin for paediatric patients using Bayesian model averaging approach
Introduction: Vancomycin has been used as a first-line treatment against methicillin-resistant Staphylococcus aureus for over 60 years and is also…
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