Introduction/Objectives: More than 50% of women take at least one medication during lactation. However, 54% of the drugs in the…
Read morePoster: Methodology - Study Design
PK/PD-INTEGRATED BAYESIAN PLATFORM DESIGN FOR PHASE II REGIMEN OPTIMISATION
Introduction: Early-phase dose-finding generally focuses on toxicity, but new approaches are shifting to a more comprehensive quantification of benefit-risks including…
Read moreTranslational pharmacology and optimisation of a first-time-in-children protocol for the evaluation of the safety, tolerability, pharmacokinetics and preliminary efficacy of BGA002 in refractory MYCN-altered tumours.
Introduction MYCN is a key oncogenic driver in several paediatric malignancies, including neuroblastoma, where its amplification is associated with rapid…
Read moreCROSS-PRODUCT POPULATION PHARMACOKINETIC MODELING OF HAEMOGLOBIN S POLYMERIZATION INHIBITORS TO OPTIMISE PAEDIATRIC PK STUDY DESIGN USING STOCHASTIC SIMULATION-ESTIMATION
Objectives Conducting pharmacokinetic (PK) studies in paediatric populations presents significant challenges due to physiological vulnerability, sampling limitations [1] and ethical…
Read moreEvaluation of the Impact of Machine-learning-informed Optimal Study Design on the Identifiability of Key Pharmacokinetic Parameters in Preclinical Intravenous Rat Pharmacokinetic Studies
Introduction: Preclinical pharmacokinetic (PK) studies for new drug candidates are typically designed empirically and in a compound agnostic manner. Optimal experimental…
Read moreOPTIMISING SAMPLING DESIGN TO ENHANCE PHARMACOKINETIC EVALUATION OF COLISTIN IN NEONATES
Background and Objectives: Gram-negative bacteria (GNB) is the most common cause of early onset sepsis (53%) and late onset neonatal…
Read moreModel‑Informed Strategies for Methocarbamol Multi‑Particulate Regimen Development: Linking Mechanistic Modelling to Formulation Design Space
Objectives: Methocarbamol is a skeletal muscle relaxant that acts by inhibiting polysynaptic reflexes in the spinal cord and subcortical areas….
Read moreModel-Informed Design of Interim Analysis for a PK Bridging Study and Optimization of Its Operating Characteristics
Introduction PK bridging studies are routinely conducted to extrapolate efficacy from one population in which efficacy has been established (reference…
Read moreMAKING SPARSE DATA INFORMATIVE: POPULATION PHARMACOKINETICS AND D-OPTIMAL DESIGN FOR ORAL CIPROFLOXACIN IN ADULTS ≥75 YEARS
Objectives: Oral ciprofloxacin remains one of the few available oral agents with activity against Pseudomonas aeruginosa. However, exposure in older…
Read moreDesign Evaluation and Optimisation with Discrete Covariates and Inter-Occasion Variability in Nonlinear Mixed Effects Models: The R Package PFIM 7.1
Objectives Several packages for design evaluation and optimisation in pharmacometrics are based on the Fisher Information Matrix (FIM). The were…
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