Objectives Population pharmacokinetic (PopPK) modeling plays a central role in model-informed drug development (MIDD); supporting decision-making throughout clinical development and…
Read morePoster: Methodology - Other topics
The Decision-Equivalence Metric (DEM) Method Based Evaluation of Biomarker Surrogacy in MASH
Objectives: Early and reliable go/no go decisions are essential for accelerating drug development in metabolic dysfunction–associated steatohepatitis (MASH). Surrogate biomarkers…
Read moreA POTENTIAL COST OF BLOCK-DIAGONAL Ω: BIASED DOSE-RESPONSE ESTIMATES IN THE PRESENCE OF EXPOSURE-RESPONSE CONFOUNDING
Introduction: In pharmacometrics, it is often (implicitly) assumed that the exposure-response relationship in a dose randomized study is unconfounded, at…
Read moreCOUNTING THE BIOCHEMICAL REACTION OCCURRENCES: A STATISTICAL IMPLICATION OF THE FIRST-ORDER RATE CONSTANTS IN KINETIC MODELS
INTRODUCTION: In biochemistry and its applied sciences such as pharmacology, first-order rate constants (FORCs) are used in kinetic models to…
Read moreQUANTIFYING THE IMPACT OF LLOQ AND ULOQ CENSORING ON M3 ESTIMATION PERFORMANCE IN NONMEM
Introduction/objectives : The analysis of pharmacokinetic (PK) clinical data is frequently complicated by censored observations, which may affect data representativeness…
Read moreBIDIRECTIONAL CONVERSION BETWEEN MRGSOLVE AND RXODE2 FOR PHARMACOMETRIC MODELS
Objectives Pharmacometric models implemented in mrgsolve [1] and rxode2 [2] are increasingly used for simulation and exploratory analyses in R…
Read moreMETHODS FOR SUBGROUP SIMILARITY ASSESSMENT IN DOSE-RESPONSE META-ANALYSIS USING A BOOTSTRAP APPROACH
Introduction and Objectives: Dose-response meta-analysis (DRMA) has gained considerable attention as an effective approach to synthesize the dose-response relationships reported…
Read moreChoosing the Right Exposure Metric: Power and Confounding in Exposure-Response (E-R) Models
Introduction: As outlined by FDA guidance [1], Exposure-Response (E-R) analyses can support dosage selection and adjustments. When a single response…
Read moreR-based Bayesian workflow for ODE pharmacometrics modeling: generalized dapagliflozin PK model as a case study
Introduction Most model-based analyses in pharmacometrics (PMx) and the associated statistical inference follow the frequentist paradigm, established in the early…
Read moreSimuRg: an R wrapper package for an AI-based pharmacometrics ecosystem
Introduction Pharmacometrics analysis can be represented as workflow comprising multiple highly specialized steps that typically include data processing, data digitization,…
Read more